Polypectomy systems, devices, and methods

ABSTRACT

A polyp removal device comprises an outer tubular body; an inner tubular body; a tubular cutter coupled to or formed as part of the distal end of the inner tubular body; a spring positioned to bias the inner tubular body in an extended direction with respect to the outer tubular body; a handle coupled to the proximal end of the outer tubular body; an actuation member movably coupled to the handle; and a disconnect mechanism for selectively coupling the actuation member to the inner tubular body and decoupling the actuation member from the inner tubular body, the disconnect mechanism is configured to automatically decouple the inner tubular body from the actuation member when the actuation member is moved in a first direction for a distance greater than a predetermined distance.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/519,490, titled POLYPECTOMY SYSTEMS, DEVICES, ANDMETHODS, filed on Jun. 14, 2017. This application is related by subjectmatter to U.S. patent application Ser. No. 15/616,148, titledPOLYPECTOMY SYSTEMS, DEVICES, AND METHODS, filed on Jun. 7, 2017, whichis a continuation of U.S. patent application Ser. No. 15/222,021, titledPOLYPECTOMY SYSTEMS, DEVICES, AND METHODS, filed on Jul. 28, 2016, whichclaims the benefit of U.S. Provisional Patent Application No.62/199,494, titled POLYPECTOMY SYSTEMS, DEVICES, AND METHODS, filed onJul. 31, 2015. Each of the foregoing applications is hereby incorporatedby reference herein in its entirety.

BACKGROUND Field

The disclosure relates generally to the field of medicine, and morespecifically to devices and methods for performing polypectomies.

Description

A polyp is an abnormal growth of tissue from a mucous membrane. Apolypectomy may be performed to remove a polyp. An endometrial oruterine polyp is an abnormal growth attached to an inner wall of theuterus. Uterine polyps are usually benign, but they can be cancerous oreventually turn into cancer.

SUMMARY

This disclosure presents various embodiments of polypectomy systems,methods, and devices for safely removing polyps, such as uterine polyps.In some embodiments, a polypectomy device is configured to be insertedthrough the vaginal canal into the uterus, and to remove polyps throughone or both of vacuum suction and mechanical separation. In someembodiments, the polypectomy devices disclosed herein are specificallydesigned to remove polyps—which are generally relatively small andgelatinous in consistency—and not necessarily designed to remove alarger and/or firmer object, such as a fibroid. This can enableembodiments disclosed herein to be smaller than, and in some casesmechanically simpler than, more robustly built tools that are intendedto remove those larger and/or firmer objects, such as fibroids. Thepolypectomy devices disclosed herein can be safer, easier to use, lowercost and/or easier to manufacture.

According to some embodiments, a polyp removal device comprises: anouter tubular body having a cylindrical outer surface, proximal anddistal ends, and an opening in the cylindrical outer surface at or nearthe distal end; an inner tubular body positioned within a lumen of theouter tubular body, the inner tubular body having proximal and distalends and being movable with respect to the outer tubular body; a tubularcutter coupled to or formed as part of the distal end of the innertubular body, the tubular cutter positioned adjacent the opening of theouter tubular body; a spring positioned to bias the inner tubular bodyin an extended direction with respect to the outer tubular body; ahandle coupled to the proximal end of the outer tubular body; anactuation member movably coupled to the handle, the actuation memberconfigured to be manipulated by a user by at least one of sliding orrotating the actuation member with respect to the handle, the actuationmember configured to be movable in at least a first direction and asecond direction with respect to the handle; and a disconnect mechanismfor selectively coupling the actuation member to the inner tubular bodyand decoupling the actuation member from the inner tubular body, thedisconnect mechanism is configured to keep the inner tubular bodycoupled to the actuation member while the actuation member is moved inthe first direction for a predetermined distance, causing the innertubular body to retract with respect to the outer tubular body, thedisconnect mechanism is further configured to automatically decouple theinner tubular body from the actuation member when the actuation memberis moved in the first direction for a distance greater than thepredetermined distance, enabling the spring to cause the inner tubularbody to extend with respect to the outer tubular body, and thedisconnect mechanism is further configured to re-couple the innertubular body to the actuation member when the actuation member is movedin the second direction.

In some embodiments, the disconnect mechanism comprises: a rotatableconnecting link biased in a direction that couples the inner tubularbody to the actuation member; and a cam surface positioned to engage theconnecting link and cause the connecting link to rotate in a directionthat decouples the inner tubular body from the actuation member,responsive to movement of the actuating member in the first direction.In some embodiments, the disconnect mechanism comprises: an elasticallybendable connecting link biased in a direction that couples the innertubular body to the actuation member; and a cam surface positioned toengage the connecting link and cause the connecting link to bend in adirection that decouples the inner tubular body from the actuationmember, responsive to movement of the actuating member in the firstdirection. In some embodiments, the first direction comprisestranslation of the actuation member in a proximal direction with respectto the handle, and the second direction comprises translation of theactuation member in a distal direction with respect to the handle. Insome embodiments, the first direction comprises rotation of theactuation member in a clockwise or counterclockwise direction withrespect to the handle, and the second direction comprises rotation ofthe actuation member in a direction opposite to the first direction withrespect to the handle. In some embodiments, the polyp removal devicefurther comprises a cam mechanism configured to cause the inner tubularbody to rotate about a longitudinal axis as the inner tubular bodyextends with respect to the outer tubular body. In some embodiments, thecam mechanism comprises a pin positioned at least partially within ahelical groove, wherein the pin is coupled to or formed as part of oneof the inner tubular body or the handle, and the helical groove iscoupled to or formed as part of the other of the inner tubular body orthe handle. In some embodiments, the cam mechanism is configured tocause the inner tubular body to rotate no more than 180 degrees aboutthe longitudinal axis as the inner tubular body extends with respect tothe outer tubular body. In some embodiments, the cam mechanism isconfigured to cause the inner tubular body to rotate no more than 270degrees about the longitudinal axis as the inner tubular body extendswith respect to the outer tubular body. In some embodiments, the polypremoval device further comprises: a cutting block positioned at thedistal end of the outer tubular body and at least partially distal tothe opening, the cutting block comprising a blunt rounded distal portionthat at least partially forms a distal tip of the polyp removal device,the cutting block further comprising a proximally extending cuttingportion positioned within the lumen of the outer tubular body, thecutting portion comprising a cylindrical outer surface, a concaveproximal face, and a cutting edge where the cylindrical outer surfacemeets the concave proximal face, wherein the tubular cutter is sized tofit at least partially within an annular shaped void between the lumenof the outer tubular body and the cylindrical outer surface of thecutting portion of the cutting block when the inner tubular body is inan extended position with respect to the outer tubular body. In someembodiments, the tubular cutter comprises a circular cutting edgepositioned at an inner diameter of a distal end of the tubular cutter.In some embodiments, the outer tubular body comprises a distal cuttingsurface at a distal end of the opening, the distal cutting surfacecomprising a shape that is not perpendicular to a longitudinal axis ofthe outer tubular body. In some embodiments, the outer tubular bodycomprises a distal cutting surface at a distal end of the opening, thedistal cutting surface comprising a shape that, when viewedperpendicular to a longitudinal axis of the outer tubular body andnormal to a center of the opening, comprises one or more roundedportions or comprises one or more portions that are oriented at anon-perpendicular angle with respect to the longitudinal axis. In someembodiments, the outer tubular body is rotatably coupled to the handle,to allow the outer tubular body to rotate about a longitudinal axis withrespect to the handle. In some embodiments, the outer tubular body isrotatably coupled to the handle via a hub, the hub comprising at leastone radially protruding member for engagement by a user to causerotation of the hub and outer tubular body with respect to the handle.In some embodiments, the polyp removal device further comprises a balldetent mechanism configured to resist rotation of the hub with respectto the handle until a preload force of the ball detent mechanism isovercome, the ball detent mechanism comprising at least a ball, a ballpreload device, and a plurality of detents for the ball to engage. Insome embodiments, the tubular cutter comprises a circular cutting edgepositioned at an inner diameter of a distal end of the tubular cutter.In some embodiments, the outer tubular body comprises a distal cuttingsurface at a distal end of the opening, the distal cutting surfacecomprising a shape that is not perpendicular to a longitudinal axis ofthe outer tubular body. In some embodiments, the outer tubular bodycomprises a distal cutting surface at a distal end of the opening, thedistal cutting surface comprising a shape that, when viewedperpendicular to a longitudinal axis of the outer tubular body andnormal to a center of the opening, comprises one or more roundedportions or comprises one or more portions that are oriented at anon-perpendicular angle with respect to the longitudinal axis.

According to some embodiments, a polyp removal device comprises: anouter tubular body having proximal and distal ends; an inner tubularbody positioned within a lumen of the outer tubular body, the innertubular body having proximal and distal ends and being movable withrespect to the outer tubular body; a handle coupled to the proximal endof the outer tubular body; an actuation member movably coupled to thehandle, the actuation member configured to cause at least translation ofthe inner tubular body with respect to the outer tubular body when theactuation member is moved with respect to the handle; a vacuum port forcoupling thereto of a vacuum source, the vacuum port being in fluidcommunication with a lumen of the inner tubular body; an opening near adistal end of the polyp removal device, the opening configured to allowfluid communication between an environment external to the polyp removaldevice and the lumen of the inner tubular body; a cutting blockpositioned at the distal end of the outer tubular body and at leastpartially distal to the opening, the cutting block comprising a bluntrounded distal portion that at least partially forms a distal tip of thepolyp removal device, the cutting block further comprising a proximallyextending cutting portion positioned within the lumen of the outertubular body, the cutting portion comprising a cylindrical outersurface, a concave proximal face, and a cutting edge where thecylindrical outer surface meets the concave proximal face; and a tubularcutter positioned at the distal end of the inner tubular body, thetubular cutter sized to fit at least partially within an annular shapedvoid between the lumen of the outer tubular body and the cylindricalouter surface of the cutting portion of the cutting block when the innertubular body is in an extended position with respect to the outertubular body.

In some embodiments, a diametral clearance between an inner diameter ofthe tubular cutter and an outer diameter of the cylindrical outersurface of the cutting portion of the cutting block is no greater than0.0025″. In some embodiments, the outer tubular body is rotatablycoupled to the handle, to allow the outer tubular body to rotate about alongitudinal axis with respect to the handle. In some embodiments, theouter tubular body is rotatably coupled to the handle via a hub, the hubcomprising at least one radially protruding member for engagement by auser to cause rotation of the hub and outer tubular body with respect tothe handle. In some embodiments, the polyp removal device furthercomprises a ball detent mechanism configured to resist rotation of thehub with respect to the handle until a preload force of the ball detentmechanism is overcome, the ball detent mechanism comprising at least aball, a ball preload device, and a plurality of detents for the ball toengage. In some embodiments, the tubular cutter comprises a circularcutting edge positioned at an inner diameter of a distal end of thetubular cutter. In some embodiments, the outer tubular body comprises adistal cutting surface at a distal end of the opening, the distalcutting surface comprising a shape that is not perpendicular to alongitudinal axis of the outer tubular body. In some embodiments, theouter tubular body comprises a distal cutting surface at a distal end ofthe opening, the distal cutting surface comprising a shape that, whenviewed perpendicular to a longitudinal axis of the outer tubular bodyand normal to a center of the opening, comprises one or more roundedportions or comprises one or more portions that are oriented at anon-perpendicular angle with respect to the longitudinal axis. In someembodiments, a ratio of a longitudinal length of the outer tubular bodyto an outer diameter of the outer tubular body is at least 100.

According to some embodiments, a polyp removal device comprises: anouter tubular body having a cylindrical outer surface, proximal anddistal ends, and an opening in the cylindrical outer surface near thedistal end; an inner tubular body positioned within a lumen of the outertubular body, the inner tubular body having proximal and distal ends andbeing longitudinally and rotationally movable with respect to the outertubular body, the inner tubular body comprising an extended position anda retracted position with respect to the outer tubular body; a tubularcutter coupled to or formed as part of the distal end of the innertubular body, the tubular cutter positioned adjacent the opening of theouter tubular body; a spring positioned to bias the inner tubular bodytoward the extended position with respect to the outer tubular body; ahandle coupled to the proximal end of the outer tubular body; a cammechanism coupled to the handle and configured to cause the innertubular body to rotate about a longitudinal axis as the inner tubularbody moves from the retracted position to the extended position withrespect to the outer tubular body; and a disconnect mechanism coupled tothe handle and configured to selectively retain the inner tubular bodyin the retracted position or release the inner tubular body from theretracted position, allowing the spring to move the inner tubular bodytoward the extended position.

In some embodiments, the cam mechanism comprises a pin positioned atleast partially within a helical groove, wherein the pin is coupled toor formed as part of one of the inner tubular body or the handle, andthe helical groove is coupled to or formed as part of the other of theinner tubular body or the handle. In some embodiments, the cam mechanismis configured to cause the inner tubular body to rotate within a rangeof 90-270 degrees about the longitudinal axis as the inner tubular bodyextends with respect to the outer tubular body. In some embodiments, thedisconnect mechanism comprises a catch that engages an actuation surfaceof the inner tubular body or a component coupled to the inner tubularbody, and wherein the catch is movable out of engagement with theactuation surface to allow the spring to move the inner tubular bodytoward the extended position. In some embodiments, the catch ispivotally movable to engage or disengage the actuation surface, and thedisconnect mechanism further comprises a spring that biases the catchtoward engagement with the actuation surface. In some embodiments, thecatch is biased toward engagement with the actuation surface, and thecatch comprises an elastically bendable material that can bend todisengage the actuation surface. In some embodiments, the disconnectmechanism comprises a manually operable release coupled to or formed aspart of the catch to enable manual movement of the catch out ofengagement with the actuation surface. In some embodiments, the polypremoval device further comprises: an actuation member movably coupled tothe handle and the disconnect mechanism, the actuation member configuredto be manipulated by a user by at least one of sliding or rotating theactuation member with respect to the handle; wherein, when the catch ofthe disconnect mechanism is in engagement with the actuation surface,movement of the actuation member with respect to the handle causesmovement of the inner tubular body with respect to the handle; andwherein, when the catch of the disconnect mechanism is not in engagementwith the actuation surface, movement of the actuation member withrespect to the handle does not cause movement of the inner tubular bodywith respect to the handle. In some embodiments, the disconnectmechanism further comprises a cam surface positioned to automaticallycause the catch to disengage the actuation surface in response tomovement of the actuation member with respect to the handle. In someembodiments, the actuation member is coupled to the disconnect mechanismthrough a geartrain or linkage that converts pivotal movement of theactuation member into sliding movement of at least a portion of thedisconnect mechanism. In some embodiments, the outer tubular body isrotatable with respect to the handle, to enable changing of a rotationalposition of the opening with respect to the handle. In some embodiments,the polyp removal device further comprises: a cutting block positionedat the distal end of the outer tubular body and at least partiallydistal to the opening, the cutting block comprising a blunt roundeddistal portion that at least partially forms a distal tip of the polypremoval device, the cutting block further comprising a proximallyextending cutting portion positioned within the lumen of the outertubular body, the cutting portion comprising a cylindrical outersurface, a concave proximal face, and a cutting edge where thecylindrical outer surface meets the concave proximal face; and whereinthe tubular cutter is sized to fit at least partially within an annularshaped void between the lumen of the outer tubular body and thecylindrical outer surface of the cutting portion of the cutting blockwhen the inner tubular body is in the extended position with respect tothe outer tubular body. In some embodiments, the tubular cuttercomprises a circular cutting edge positioned at an inner diameter of adistal end of the tubular cutter. In some embodiments, the outer tubularbody comprises a distal cutting surface at a distal end of the opening,the distal cutting surface comprising a shape that is not perpendicularto the longitudinal axis. In some embodiments, the outer tubular bodycomprises a distal cutting surface at a distal end of the opening, thedistal cutting surface comprising a shape that, when viewedperpendicular to the longitudinal axis and normal to a center of theopening, comprises one or more rounded portions or comprises one or moreportions that are oriented at a non-perpendicular angle with respect tothe longitudinal axis.

According to some embodiments, a polyp removal device comprises: anouter tubular body having a cylindrical outer surface, proximal anddistal ends, and an opening in the cylindrical outer surface near thedistal end; an inner tubular body positioned within a lumen of the outertubular body, the inner tubular body having proximal and distal ends andbeing movable with respect to the outer tubular body; a cutter coupledto or formed as part of the distal end of the inner tubular body, thecutter positioned adjacent the opening of the outer tubular body; aspring positioned to bias the inner tubular body in a retracteddirection with respect to the outer tubular body; a handle coupled tothe proximal end of the outer tubular body; an actuation member movablycoupled to the handle, the actuation member configured to be manipulatedby a user by at least one of sliding or rotating the actuation memberwith respect to the handle, the actuation member configured to bemovable in at least a first direction and a second direction withrespect to the handle; and a disconnect mechanism for selectivelycoupling the actuation member to the inner tubular body and decouplingthe actuation member from the inner tubular body, the disconnectmechanism is configured to keep the inner tubular body coupled to theactuation member while the actuation member is moved in the firstdirection for a predetermined distance, causing the inner tubular bodyto extend with respect to the outer tubular body, the disconnectmechanism is further configured to automatically decouple the innertubular body from the actuation member when the actuation member ismoved in the first direction for a distance greater than thepredetermined distance, enabling the spring to cause the inner tubularbody to retract with respect to the outer tubular body, and thedisconnect mechanism is further configured to re-couple the innertubular body to the actuation member when the actuation member is movedin the second direction.

In some embodiments, the disconnect mechanism comprises: a rotatableconnecting link biased in a direction that couples the inner tubularbody to the actuation member; and a cam surface positioned to engage theconnecting link and cause the connecting link to rotate in a directionthat decouples the inner tubular body from the actuation member,responsive to movement of the actuating member in the first direction.In some embodiments, the disconnect mechanism comprises: an elasticallybendable connecting link biased in a direction that couples the innertubular body to the actuation member; and a cam surface positioned toengage the connecting link and cause the connecting link to bend in adirection that decouples the inner tubular body from the actuationmember, responsive to movement of the actuating member in the firstdirection. In some embodiments, the first direction comprisestranslation of the actuation member in a distal direction with respectto the handle, and the second direction comprises translation of theactuation member in a proximal direction with respect to the handle. Insome embodiments, the first direction comprises rotation of theactuation member in a clockwise or counterclockwise direction withrespect to the handle, and the second direction comprises rotation ofthe actuation member in a direction opposite to the first direction withrespect to the handle. In some embodiments, the polyp removal devicefurther comprises a cam mechanism configured to cause the inner tubularbody to rotate about a longitudinal axis as the inner tubular bodyretracts with respect to the outer tubular body. In some embodiments,the cam mechanism comprises a pin positioned at least partially within ahelical groove, wherein the pin is coupled to or formed as part of oneof the inner tubular body or the handle, and the helical groove iscoupled to or formed as part of the other of the inner tubular body orthe handle. In some embodiments, the cam mechanism is configured tocause the inner tubular body to rotate no more than 180 degrees aboutthe longitudinal axis as the inner tubular body retracts with respect tothe outer tubular body. In some embodiments, the cam mechanism isconfigured to cause the inner tubular body to rotate no more than 270degrees about the longitudinal axis as the inner tubular body retractswith respect to the outer tubular body. In some embodiments, the outertubular body is rotatably coupled to the handle, to allow the outertubular body to rotate about a longitudinal axis with respect to thehandle. In some embodiments, the outer tubular body is rotatably coupledto the handle via a hub, the hub comprising at least one radiallyprotruding member for engagement by a user to cause rotation of the huband outer tubular body with respect to the handle. In some embodiments,the polyp removal device further comprises a ball detent mechanismconfigured to resist rotation of the hub with respect to the handleuntil a preload force of the ball detent mechanism is overcome, the balldetent mechanism comprising at least a ball, a ball preload device, anda plurality of detents for the ball to engage.

According to some embodiments, a polyp removal device comprises: anouter tubular body having proximal and distal ends; an inner tubularbody positioned within a lumen of the outer tubular body, the innertubular body having proximal and distal ends and being movable withrespect to the outer tubular body; a handle coupled to the proximal endof the outer tubular body; an actuation member movably coupled to thehandle, the actuation member configured to cause movement of the innertubular body with respect to the outer tubular body when the actuationmember is moved with respect to the handle; a vacuum port for couplingthereto of a vacuum source, the vacuum port being in fluid communicationwith a lumen of the inner tubular body; and an opening near a distal endof the polyp removal device, the opening configured to allow fluidcommunication between an environment external to the polyp removaldevice and the lumen of the inner tubular body, wherein a size of theopening is variable based on the movement of the inner tubular body withrespect to the outer tubular body.

In some embodiments, the inner tubular body is translatable or rotatablewith respect to the outer tubular body, but not both. In someembodiments, the polyp removal device further comprises a blunt distaltip. In some embodiments, the opening is formed by unsharpened edges ofthe outer tubular body and inner tubular body. In some embodiments, theopening is formed by: a first protruding member extending from thedistal end of the outer tubular member; and a second protruding memberextending from the distal end of the inner tubular member, wherein thefirst and second protruding members each comprise a semicircularcross-sectional shape at a cross section taken through a transverseplane, and wherein the second protruding member is nested within thefirst protruding member and is rotatable about a longitudinal axis withrespect to the first protruding member. In some embodiments, the openingis formed by: a first protruding member extending from the distal end ofthe outer tubular member; and a second protruding member extending fromthe distal end of the inner tubular member, the second protruding memberbeing nested within the first protruding member and rotatable about alongitudinal axis with respect to the first protruding member, whereinthe first protruding member comprises an arc-shaped cross-sectionalshape, at least at a cross section taken through a transverse planelocated at a midpoint of the first protruding member in a longitudinaldirection, and wherein the second protruding member comprises anarc-shaped cross-sectional shape, at least at a cross section takenthrough a transverse plane located at a midpoint of the secondprotruding member in the longitudinal direction. In some embodiments,angular lengths of the arc-shaped cross-sectional shapes are equal. Insome embodiments, an angular length of the arc-shaped cross-sectionalshape of the first protruding member is greater than an angular lengthof the arc-shaped cross-sectional shape of the second protruding member.In some embodiments, an angular length of the arc-shaped cross-sectionalshape of the first protruding member is less than an angular length ofthe arc-shaped cross-sectional shape of the second protruding member. Insome embodiments, an angular length of the arc-shaped cross-sectionalshape of the first protruding member is equal to or greater than 180degrees. In some embodiments, a distal tip of the second protrudingmember comprises a lip extending transversely beyond a longitudinalplane that passes through end points of the arc-shaped cross-sectionalshape of the second protruding member. In some embodiments, the lip issized and positioned such that the lip prevents the second protrudingmember from translating distally beyond the first protruding member whenthe second protruding member and first protruding member are positionedrotationally opposite one another. In some embodiments, a distal end ofthe first protruding member comprises a blunt rounded surface. In someembodiments, the first protruding member comprises a u-shaped cuttingedge configured to cooperate with a u-shaped cutting edge of the secondprotruding member to cut polyp tissue positioned therebetween when thesecond protruding member rotates with respect to the first protrudingmember. In some embodiments, a distal end of the first protruding membercomprises a flat surface. In some embodiments, the opening is formed by:an outer aperture in a side wall of the outer tubular member, the outeraperture comprising distal and proximal cutting edges; and an inneraperture in a side wall of the inner tubular member, the inner aperturecomprising distal and proximal cutting edges, wherein translation of theinner tubular member in a proximal direction with respect to the outertubular member causes the distal cutting edge of the inner aperture toapproach the proximal cutting edge of the outer aperture, and whereintranslation of the inner tubular member in a distal direction withrespect to the outer tubular member causes the proximal cutting edge ofthe inner aperture to approach the distal cutting edge of the outeraperture. In some embodiments, the inner tubular member comprises ablunt rounded distal tip, and the outer tubular member comprises an opendistal tip, and wherein translation of the inner tubular member in thedistal direction with respect to the outer tubular member causes theblunt rounded distal tip of the inner tubular member to protrudedistally from the open distal tip of the outer tubular member. In someembodiments, the inner tubular member is translatable with respect tothe outer tubular member, but not rotatable with respect to the outertubular member. In some embodiments, a first longitudinal length,measured from the distal cutting edge of the outer aperture to thedistal tip of the outer tubular member, is equal to or greater than asecond longitudinal length, measured from the proximal cutting edge ofthe inner aperture to the distal cutting edge of the inner aperture. Insome embodiments, the first longitudinal length is no greater than 110%of the second longitudinal length. In some embodiments, the firstlongitudinal length is no greater than 120% of the second longitudinallength. In some embodiments, a longitudinal length of the opening at itsmaximum size is no less than 5 millimeters. In some embodiments, alongitudinal length of the opening at its maximum size is no less than10 millimeters. In some embodiments, the outer tubular body comprises anouter diameter no greater than 0.125 inches. In some embodiments, thepolyp removal device further comprises: a second opening near the distalend of the polyp removal device configured to allow fluid communicationbetween the environment external to the polyp removal device and thelumen of the inner tubular body. In some embodiments, the polyp removaldevice further comprises: a cutting block positioned at the distal endof the outer tubular body, the cutting block having an outer diametersized to fit with an inner diameter of the distal end of the innertubular member, wherein the cutting block comprises a proximal face thatis inclined with respect to a transverse plane of the outer tubularmember. In some embodiments, the distal end of the inner tubular membercomprises a circular cutting edge oriented parallel to the transverseplane. In some embodiments, the distal end of the inner tubular membercomprises a cutting edge that is inclined with respect to the transverseplane. In some embodiments, a transverse width of the opening is atleast 60% of an outer diameter of the outer tubular member. In someembodiments, the handle comprises a grip portion shaped to be gripped bya human hand and protruding radially, the grip portion protruding in adirection oriented at an angle with respect to the opening within arange of 90-180 degrees.

According to some embodiments, a polyp removal device comprises: anouter tubular body having proximal and distal ends; an inner tubularbody positioned within a lumen of the outer tubular body, the innertubular body having proximal and distal ends and being movable withrespect to the outer tubular body; a handle coupled to the proximal endof the outer tubular body; an actuation member movably coupled to thehandle, the actuation member configured to cause movement of the innertubular body with respect to the outer tubular body when the actuationmember is moved with respect to the handle; and a vacuum port forcoupling thereto of a vacuum source, the vacuum port being in fluidcommunication with a lumen of the inner tubular body, wherein the distalend of the outer tubular body comprise an opening configured to allowfluid communication between an environment external to the polyp removaldevice and the lumen of the inner tubular body, and wherein the distalend of the inner tubular body is shaped such that the movement of theinner tubular body with respect to the outer tubular body causes atleast a portion of the opening of the outer tubular body to be blockedby the distal end of the inner tubular body.

In some embodiments, the opening of the distal end of the outer tubularbody is formed by a first protruding member comprising an arc-shapedcross-sectional shape, at least at a cross section taken through atransverse plane located at a midpoint of the first protruding member ina longitudinal direction. In some embodiments, the distal end of theinner tubular member comprises a second protruding member being nestedwithin the first protruding member and rotatable about a longitudinalaxis with respect to the first protruding member, and wherein the secondprotruding member comprises an arc-shaped cross-sectional shape, atleast at a cross section taken through a transverse plane located at amidpoint of the second protruding member in a longitudinal direction.

According to some embodiments, a polyp removal device comprises: anouter tubular body having proximal and distal ends, the distal endcomprising an opening configured to allow fluid communication between anenvironment external to the polyp removal device and a lumen of theouter tubular body; a handle coupled to the proximal end of the outertubular body, the handle comprising a body and an actuating mechanism; acutting member disposed within the distal end of the outer tubular body,the cutting member being movable with respect to the outer tubular body,the cutting member comprising at least one cutting edge configured tocut polyp tissue that has been positioned through the opening of theouter tubular body; an actuation member functionally coupled between theactuating mechanism and cutting member, wherein movement of theactuating mechanism with respect to the body of the handle causes theactuation member to move the cutting member with respect to the outertubular body; and a vacuum port for coupling thereto of a vacuum source,the vacuum port being in fluid communication with the lumen of the outertubular body.

In some embodiments, the actuating mechanism comprises a trigger. Insome embodiments, the actuation member comprises a rod.

According to some embodiments, a method of removing a polyp from a humanuterus comprises: inserting a medical instrument into the uterus, themedical instrument comprising a working channel; inserting a polypremoval device through the working channel of the medical instrument;extending a distal end of the polyp removal device into the uterusbeyond a distal end of the working channel of the medical device;positioning at least a portion of a polyp through an opening in thedistal end of the polyp removal device; operating an actuation member ofthe polyp removal device, causing the opening in the distal end of thepolyp removal device to reduce in size, separating the at least aportion of the polyp from the uterus; and transferring the separatedportion of the polyp to a proximal end of the polyp removal device viasuction. In some embodiments, the polyp removal device comprises any ofthe polyp removal devices described herein.

According to some embodiments, a tissue removal device comprises: anouter tubular body that has a proximal end, a distal end with a roundedtip, and an inner lumen therebetween; a housing; and an inner tubularbody with distal end with a rounded tip and inner lumen, wherein distalend of the outer tubular body has a cutaway that is at least half of thedistal tip and that is at least 90 degrees and comprises non-bevelededges that begin from outer tubular body and terminate at the end of therounded end of the distal tip of the outer tubular body, and saidcutaway serves as an tissue receptacle; wherein inner tubular body has acutaway that is at least half of the distal tip that is at least 90degrees, with non-beveled edges that begin from inner tubular body andterminate at the rounded end of the distal tip of the inner tubularbody, the inner tubular body cutaway configured as a tissue receptacle,the inner tubular body cutaway forms a chamber that cooperates with thelumen of the outer tubular body when the inner tubular body rotates; andwherein lumen of the inner tubular body is configured to receive tissuethat is cut off from the rotation of the inner tubular body when thecutaways of inner tubular body and cutaway of the outer tubular bodycontain tissue.

According to some embodiments, a tissue removal device comprises: anouter tubular body that has a proximal end, a distal end with a roundedtip, and an inner lumen therebetween housing; an inner tubular body witha distal end with a coaxially removed tip with non-beveled edges; andwherein distal end of the outer tubular body has two parallel cutawayswith non-beveled edges, that do not terminate at the distal tip, thecutaways act as a tissue receptacle; and wherein inner tubular body cantranslate to the distal end of the lumen of the out tubular body, fullextension of the inner tubular body forms a chamber that cooperates withthe lumen of the outer tubular body when the inner tubular body istranslated to the distal tip of the outer tubular body; wherein lumeninner tubular body receives tissue that is cut off from the translationof the inner tubular body when either of the cutaways of the outertubular body revives tissue; and wherein proximal ends of inner tubularbody and outer tubular body that ends in connectors for an exit portthat connects to an external vacuum source.

According to some embodiments, a tissue removal device comprises: anouter tubular body that has a proximal end, a distal end with a roundedtip, and an inner lumen therebetween housing a cutter; wherein outertubular body has an aperture towards the distal end of the tip that isconfigured as a tissue receptacle; wherein cutter is an inner body withan inner lumen and a distal tip has an aperture with beveled edgestowards the distal end of the tip that is configured as a tissuereceptacle, aperture of the inner tubular body and aperture of outertubular body square evenly; wherein translation of inner tubular body,whether elongation or retraction of inner tubular body, creates achamber with the lumen of the outer tubular body, lumen of inner tubularbody holds severed tissue created from translation of the beveled edgesof the inner tube; and wherein proximal ends of inner tubular body andouter tubular body ends in connectors for an exit port that connects toan external vacuum source.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features, aspects, and advantages of the presentinvention are described in detail below with reference to the drawingsof various embodiments, which are intended to illustrate and not tolimit the invention. The drawings comprise the following figures inwhich:

FIGS. 1A and 1B illustrate an embodiment of a polypectomy device thatutilizes translation of an inner tubular member to remove polyps.

FIGS. 2A and 2B illustrate an embodiment of a polypectomy device thatutilizes rotation of an inner tubular member to remove polyps.

FIG. 3 illustrates an example of a hysteroscope with a straight workingchannel that may be utilized with embodiments of polypectomy devicesdisclosed herein.

FIG. 4 illustrates an example of the polypectomy device of FIG. 1A inuse with the scope of FIG. 3 and a human uterus.

FIGS. 5A-5C illustrate additional details of a distal tip portion of thepolypectomy device of FIG. 1A.

FIGS. 6A-6E illustrate additional details of a distal tip portion of thepolypectomy device of FIG. 2A.

FIGS. 7A-7E illustrate another embodiment of a distal tip configurationof a polypectomy device.

FIGS. 8A-8F illustrate another embodiment of a distal tip configurationof a polypectomy device.

FIGS. 9A-9G illustrate another embodiment of a distal tip configurationof a polypectomy device.

FIGS. 10A-10G illustrate another embodiment of a distal tipconfiguration of a polypectomy device.

FIGS. 11A-11G illustrate another embodiment of a distal tipconfiguration of a polypectomy device.

FIGS. 12A-12F illustrate another embodiment of a distal tipconfiguration of a polypectomy device.

FIGS. 13A-13C illustrate another embodiment of a distal tipconfiguration of a polypectomy device.

FIGS. 14A-14F illustrate another embodiment of a distal tipconfiguration of a polypectomy device.

FIGS. 15A-15C illustrate embodiments of material that can be used in apolypectomy device, the material having a sharpened or unsharpened edge.

FIGS. 16A and 16B illustrate additional details of the handle portion ofthe embodiment of FIG. 1A.

FIGS. 17A and 17B illustrate additional details of the handle portion ofthe embodiment of FIG. 2A.

FIGS. 18A and 18B illustrate another embodiment of a handle portion of apolypectomy device.

FIGS. 19A-191 illustrate another embodiment of a polypectomy device.

FIGS. 20A-20C illustrate another embodiment of a polypectomy device.

FIG. 21 illustrates a portion of another embodiment of a polypectomydevice.

FIGS. 22A-22C illustrate details of a distal tip portion of anotherembodiment of a polypectomy device.

FIG. 23 illustrates an embodiment of a method of performing apolypectomy.

FIGS. 24A-24C illustrate another embodiment of a distal tipconfiguration of a polypectomy device.

FIGS. 25A-25U illustrate another embodiment of a polypectomy device.

FIGS. 26A-26F illustrate an embodiment of a mechanism for controllingmovement of a cutter.

FIGS. 27A-27D illustrate another embodiment of a mechanism forcontrolling movement of a cutter.

FIGS. 28A-28D illustrate another embodiment of a mechanism forcontrolling movement of a cutter.

FIGS. 29A-29C illustrate another embodiment of a mechanism forcontrolling movement of a cutter.

FIGS. 30A-30C illustrate an embodiment of an outer tubular member of apolypectomy device.

FIGS. 31A-31D illustrate another embodiment of a mechanism forcontrolling movement of a cutter.

FIGS. 32A-32C illustrate another embodiment of an outer tubular memberof a polypectomy device.

FIGS. 33A-33D illustrate another embodiment of an outer tubular memberof a polypectomy device.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Although several embodiments, examples, and illustrations are disclosedbelow, it will be understood by those of ordinary skill in the art thatthe invention described herein extends beyond the specifically disclosedembodiments, examples, and illustrations and includes other uses of theinvention and obvious modifications and equivalents thereof. Embodimentsof the invention are described with reference to the accompanyingfigures, wherein like numerals refer to like elements throughout. Theterminology used in the description presented herein is not intended tobe interpreted in any limited or restrictive manner simply because it isbeing used in conjunction with a detailed description of certainspecific embodiments of the invention. In addition, embodiments of theinvention can comprise several novel features and no single feature issolely responsible for its desirable attributes or is essential topracticing the inventions herein described. Further, it should beunderstood that any of the examples herein are non-limiting. As such,the inventions disclosed herein are not limited to any particularembodiments, aspects, concepts, structures, functionalities, or examplesdescribed herein.

A polyp is an abnormal growth of tissue from a mucous membrane. Apolypectomy may be performed to remove a polyp. An endometrial oruterine polyp is an abnormal growth attached to an inner wall of theuterus. Uterine polyps are usually benign, but they can be cancerous oreventually turn into cancer. One method of removing uterine polyps is ahysteroscopic polypectomy, in which a hysteroscopic resectoscope ispassed into the uterus along with a loop wire. An electrical current maybe passed through the loop wire in order to cut the polyp by increasingthe loop temperature by 100° C. to 200° C. Such a technique has its ownset of challenges. The surgeon has to manually remove the cut polyp,which is time-consuming. Further, the use of electrocautery to cut thetissues damages the uterine tissues and may impair the ability of theuterus to sustain a pregnancy. For this reason, reproductiveendocrinologists may not even use such a technique, for fear that theyare liming the tissues where a fertilized egg might implant. Also, aloop wire may not always remove the entire polyp, which can meanrepeating the procedure later on. A loop wire also creates a risk ofthermal injury to surrounding tissue, and it is especially dangerous ifaccidentally pushed through the uterine wall contacting sensitive boweltissues. Morbidity and mortality are known complications of loop uterineperforations creating accidental bowel thermal injuries. Additionally,most patients would require anesthesia in order to mitigate the pain ofthe heat of the wire loop on sensitive tissues lining the uterus.Finally, if a monopolar wire loop is employed, a non-electrolytic fluidis required for distending the uterus, which may lead to sodiumimbalances or fluid overloading in the patient.

Another potential way to remove uterine polyps is to utilize amechanical device designed to cut uterine fibroids (also calledleiomyomas or myomas) from the uterine wall. A fibroid is a growth inthe uterus that often grows to be much larger than a typical polyp.Further, a fibroid is typically formed of a tougher, more fibrotictissue than polyps, which are somewhat gelatinous in consistency.Because of the general size and toughness of fibroids, tools that havebeen designed to remove fibroids are more robustly built, higher poweredtools that utilize a sharpened blade, drilling mechanism, and/or thelike to gradually break up and extract a fibroid. Although such a designmay be used to remove a polyp, doing so is overkill for the task at handand can introduce various unnecessary safety risks and mechanicallycomplicated devices. For example, a sharp and robust fibroid removaltool could potentially unintentionally cause trauma to adjacent uterinewall tissue and/or even puncture the uterine wall. Further, because afibroid removal tool is intended to cut into relatively tough material,the cutting features of the tool are necessarily designed to berelatively robust. This causes the tool to be larger in design and/oruse thicker tubing than is desirable or necessary for safe and efficientpolyp removal. They also include motorized power delivery systems thatare necessary to provide the energy necessary to cut the fibroid.

Ideally, a polypectomy would be able to be performed in a doctor'soffice setting rather than in a hospital surgical setting. However,because the existing methods for removing polyps, such as uterinepolyps, require a high level of skill, expensive equipment, and/or comealong with significant levels of risk, polypectomies are typically notperformed in an office setting. The devices, systems, and methodsdisclosed herein, however, can provide for safer and more cost-effectiveways of performing polypectomies in an office setting.

The removal of uterine polyps via a hysteroscopic polypectomy posesvarious challenges as discussed above. Accordingly, there is a demandfor devices and methods, as disclosed herein, for addressing some of theshortcomings associated with a traditional hysteroscopic polypectomy.

Various embodiments disclosed herein present safer and more efficientpolyp removal devices, methods, and systems. In some embodiments, apolypectomy device comprises an elongate tube having a handle with atrigger or other actuating mechanism at a proximal end and one or moreopenings (e.g., opening, hole, aperture, window, cutout, and/or thelike) at a distal end. The one or more openings at the distal end may besized and configured (1) to enable a polyp to be aspirated therethroughusing vacuum, and/or (2) to mechanically separate the polyp from theuterine wall using a movable member operably coupled to the trigger orother actuating mechanism.

In some embodiments, the configuration of the distal end of thepolypectomy device is desirably designed such that a relatively largeopening is used, the relatively large opening being big enough to acceptas much of a polyp as possible at any one time. This is different than atypical fibroid removal device that needs to gradually cut or grind awayat a fibroid and therefore needs to be relatively robust. Because polypsare of a softer consistency than fibroids, the tubing used for thepolypectomy device may be thinner than with a fibroid removal tool,enabling the polypectomy device to have a larger inner lumen, thusenabling larger tissue pieces to pass therethrough. Further, because themechanical stresses present on the cutting features of the distal end ofa polypectomy device are less than with a fibroid removal device, largeropenings at the distal end of the polypectomy device can be present,thus enabling larger pieces of tissue to be removed at any one time.

In some embodiments, a polypectomy device as disclosed herein comprisesone or more openings at its distal end that are sized and configured toaccept therethrough an entire polyp, for removal of the entire polyp inone stroke of the cutting blade/surface. The disclosure is not limitedto such a configuration, however, and in some embodiments or someinstances, only a portion of a polyp may be able to fit through the oneor more openings at the distal end of the device at any one time.

The polypectomy devices, systems, and methods disclosed herein providevarious benefits, such as easier and safer removal of polyps, fasterremoval of polyps, more efficient removal of polyps, lower cost andeasier manufacturing of the surgical instrument, and/or the like. Someof the features of some of the embodiments disclosed herein that help toprovide these features include, but are not limited to, providing arelatively large opening at a distal end of the device; providing morethan one opening at the distal end of the device; utilizing an innertubular member coupled to or comprising a cutting surface thattranslates or rotates with respect to an outer tubular member, but notboth; providing a cutting surface that is unsharpened or blunt;providing a blunt tip to the polypectomy device; providing an opening ina distal end of the polypectomy device that opens on both the side(s) ofthe distal end and the distal tip of the distal end; providing a cuttingmember that cuts in two directions, such as in the extend and retractdirections or in the clockwise and counterclockwise directions; and/orthe like.

In some embodiments, the devices and methods disclosed herein allow forcutting and removing tissue. In some embodiments, the devices andmethods disclosed herein allow for cutting and removing tissuesimultaneously. This may reduce the operating time needed for apolypectomy procedure. This may reduce the patient's exposed toanesthesia and lower the risk of fluid overloading.

In some embodiments, the devices and methods disclosed herein allow forremoval of tissue using vacuum or suction pressure. This may allow forimproved removal of the polyp or tissue. This may allow for less damageto occur to the uterus. This may allow for the use of anelectrolytically balanced saline solution to distend the uterus, unlikethe use of electric current to excise tissue which necessitates the useof non-electrolytic solutions for the same purpose. This may reduce therisk of electrolyte imbalance and/or thermal injury.

Polypectomy Devices

FIGS. 1A and 2A illustrate two example embodiments of polypectomydevices as disclosed herein. FIGS. 1B and 2B illustrate close-up viewsof the distal ends of the polypectomy devices, respectively. Withreference to FIGS. 1A and 1B, the polypectomy device 100 comprises ahandle 102 and an outer elongate tubular member 104. The outer tubularmember 104 comprises a distal end 106 configured for receiving andremoving a polyp. In this embodiment, the distal end comprises twoelongate openings 108 positioned opposite one another. These openings108 are adjacent to supporting arms 110, which support a blunt roundedtip 112 at the distalmost end of the polypectomy device 100. Thepolypectomy device 100 further comprises an actuating member (e.g.,trigger, switch, lever, button, or the like) 112 coupled to the handle102. In this embodiment, the actuating member 112 is shaped andconfigured to engage a finger of a human hand, such as a user's thumb orindex finger, and is configured to translate back and forth along orparallel to a longitudinal axis of the polypectomy device 100. Theactuating member 112 is functionally coupled to an inner tubular member114 which also translates back and forth along the longitudinal axisalong with the actuating member 112. Accordingly, movement of theactuating member 112 causes relative movement of the inner tubularmember 114 with respect to the outer tubular member 104.

The polypectomy device 100 further comprises a vacuum port 116configured to be coupled to a vacuum source, such as via a hose. In thisembodiment, the vacuum port 116 is attached to a proximal end of thehandle 102 and comprises a fitting that is in fluid communication withan internal lumen of the inner tubular member 114. In use, the outertubular member 104 of the polypectomy device 100 can be inserted througha working channel of a scope (e.g., the example scope shown in FIG. 3),causing the distal end 106 to protrude into the uterus. The doctor canthen position, via manipulation of the handle 102, one or more of theopenings 108 adjacent a polyp to be removed. Next, the doctor canactivate the vacuum source, such as by activating a foot pedal or thelike, causing the polyp (or at least a portion of the polyp) to beaspirated at least partially into one of the openings 108 of the distalend 106. Although this embodiment includes two openings 108, otherembodiments may have only one opening or more than two openings. It maybe desirable in some embodiments to have only one opening, or to have away of temporarily blocking other openings (such as a sliding orrotating shutter, window, and/or the like), since, once a polyp isaspirated through one opening, the vacuum suction may start to aspiratedistention fluid in through any remaining openings (i.e. through thepath of least resistance). If there is only one opening, or the otheropenings can temporarily be blocked, however, the vacuum suction can befocused on the polyp being removed.

In some embodiments, because polyps typically have a generallygelatinous consistency, vacuum suction alone may be sufficient toseparate the polyp from the uterine wall. In that case, the polyp willbe aspirated into the inner lumen of the inner tubular member 114 andproceed back through the inner tubular member 114 toward the handle 102(and potentially out through the vacuum port 116), for collection ordisposal. In some embodiments, although vacuum suction alone may besufficient to separate a polyp from the uterine wall, it can bedesirable to also or alternatively have a mechanical means of separatingthe polyp and/or helping to separate the polyp. For example, withreference to the polypectomy device 100 illustrated in FIGS. 1A and 1B,the inner tubular member 114 is configured to translate forward ordistally with respect to the outer tubular member 104, causing narrowingof and/or closure of the openings 108, pinching of the polyp between thedistal face of the inner tubular member 114 and the distal edge(s) ofthe opening(s) 108, and causing the polyp to be separated or sliced offmechanically.

One reason it can be desirable to have a mechanical means of separationin combination with or even in lieu of using vacuum is that, during aprocedure such as a polypectomy, the uterus is typically distended usinga fluid pumped into the uterus. Any vacuum that aspirates a polyp intothe polypectomy device or tool may also cause removal of at least someof the distention fluid from the uterine cavity. If a relatively smallamount of fluid is removed, then the procedure may not be substantiallyaffected. However, if a larger amount of fluid is caused to be removed,this may need to be dealt with, such as by reintroducing new fluid whilethe removal is taking place, stopping the polyp removal procedure andadding more fluid, and/or the like. Such procedures can make apolypectomy a more complicated and difficult surgery, and thus desirablycan be avoided by use of various devices disclosed herein.

One way that polypectomy devices disclosed herein can limit the loss ofdistention fluid is that vacuum suction may be used only to retrieve aremoved polyp or portion of a polyp after it has been mechanicallyseparated by, for example, the translation or rotation of the innertubular member 114 with respect to the outer tubular member 104. Forexample, a doctor may (1) manually manipulate the device (e.g., via thehandle 102) such that a polyp is positioned through one or more openings108, (2) manipulate the actuating member 112 to cause the inner tubularmember 114 to translate and separate the polyp from the uterus, and (3)then actuate suction to cause the already separated polyp to beaspirated proximally through the inner lumen of the inner tubular member114 for collection. In this example, very little if any distention fluidwould be lost, because the doctor would be able to keep the innertubular member 114 at a distalmost position, thus substantially or fullyclosing off the openings 108 during retrieval of the polyp. In someembodiments, at least some leakage from the openings 108 (or elsewhere)to the inner lumen of the inner tubular member 114 may be desirable,even when the inner tubular member 114 is positioned fully forward ordistal, to facilitate transfer of the polyp from the distal end to theproximal end.

Another way polypectomy devices disclosed herein can limit loss ofdistention fluid is that a doctor may use the vacuum or suction toaspirate a polyp (or portion of a polyp) in through one or more openings108, but then use mechanical motion of the inner tubular member 114 toseparate the polyp from the uterine wall. The process of aspirating apolyp or portion of a polyp into an opening 108 will generally requireless powerful suction than would be required to actually separate thepolyp from the uterine wall using suction alone. Accordingly, byutilizing vacuum or suction to introduce the polyp or portion of a polypthrough the openings 108, but then using mechanical means, such as thetranslating inner tubular member 114, to separate the polyp from theuterine wall, the suction can be most efficiently utilized and loss ofdistention fluid can be minimized. In some embodiments, at least somesuction may still be applied during mechanical operation of the innertubular member 114, such as to keep the polyp aspirated through theopening 108 during mechanical separation.

It should be noted that, although various embodiments disclosed hereinare described in terms of an inner tubular member concentricallypositioned within an outer tubular member, and a removed polyp beingaspirated through the inner lumen of the inner tubular member, variousother designs that accomplish a similar result may be utilized. Forexample, instead of using an inner tubular member, an actuation rod orother mechanism may be used to move a cutting surface or blade at thedistal end of the polypectomy device. In that case, the removed polypwould be aspirated through the lumen of the outer tubular member,because there would be no need for an inner tubular member positionedwithin the outer tubular member. One example of such a configuration isshown in FIGS. 12A-12F, described in greater detail below. A similarconfiguration (e.g., using an actuating rod or similar to move thecutting portion at the distal end of the device) could be used with anyof the other embodiments disclosed herein, including, but not limitedto, the various distal end configurations illustrated in FIGS. 5A-5C,6A-6E, 7A-7E, 8A-8F, 9A-9G, 10A-10G, 11A-11G, 13A-13C, and 14A-14F. Forthe embodiments configured to use longitudinal translation of a cuttingmember at the distal end, such an actuating rod could be directlycoupled to the cutting member. For the embodiments configured to userotational motion of a cutting member at the distal end, such anactuating rod could be coupled to the cutting member through a linkagemechanism, gear train, and/or the like that converts translation of theactuating rod into rotation of the cutting mechanism.

In some embodiments, movement of the inner tubular member 114 may becompletely manually controlled by, for example, a doctor moving theactuating member 112 forward and backward along the longitudinal axis.In some embodiments, the actuating member and/or inner tubular member114 may be biased or spring-loaded, such that the actuating member 112is configured to be manually actuated in one direction, but will thenautomatically return to the starting point when the doctor or userreleases the pressure used to initially move the actuating member 112.Further, in some embodiments, a polypectomy device may compriseelectrical actuation, pneumatic actuation, hydraulic actuation and/orthe like. For example, a button, trigger, foot pedal, and/or the likemay be configured to actuate or activate a motor that causes movement ofthe inner tubular member 114 with respect to the outer tubular member104. Further, although the embodiment illustrated in FIG. 1A illustratesan actuating member or trigger 112 that is directly coupled to the innertubular member 114, meaning their relative motion is a one-to-onerelationship, other embodiments may utilize other actuating ortriggering mechanisms. For example, an actuating member may be coupledto a gear train that enables more precise control, provides a mechanicaladvantage, enables translation of one direction of motion of theactuating member into a different direction of motion of the innertubular member, converts translating motion into rotating motion and/orvice versa, and/or the like.

As shown in FIG. 1B, the distal end 106 of the polypectomy device 100comprises a blunt rounded tip 112. It can be desirable to have a blunttip in a polypectomy device as disclosed herein, because this can helpto avoid unintentional trauma or injury to the uterine wall.Accordingly, with a design such as shown in FIG. 1B, if the distal tipof the polypectomy device 100 contacts or rubs up against a portion ofthe uterine wall, the risk that this contact will cause trauma to theuterine wall is reduced over a design that would have a sharper distaltip. This is in contrast to certain other medical instruments, such asbiopsy instruments, that comprise a sharp distal tip, because they areintended to puncture tissue in obtaining a tissue sample. Such a designused with a polypectomy device as disclosed herein could be dangerous,because the sharp tip could unintentionally puncture the uterine wall.

In addition to comprising a blunt tip, various embodiments disclosedherein comprise few, if any, sharpened surfaces at the distal end of thepolypectomy device (i.e. the portion of the polypectomy device that willextend out of the scope's working channel into the uterus). For example,although in various embodiments the inner tubular member, such as innertubular member 114 of FIG. 1B, acts somewhat as a blade to separate thepolyp from the uterine wall, because of the generally gelatinousconsistency of a polyp, the inner tubular member 114 or similar does notnecessarily need to be sharpened. Accordingly, in some embodiments, theinner tubular member or blade or cutting surface of the inner tubularmember is not sharpened and/or may comprise a smooth, blunt, and/or thelike surface. Further, the edges of the outer tubular member 104 thatdefined the one or more openings 108 may be unsharpened, smooth, blunt,and/or the like. In such a configuration, where little or no sharpsurfaces are present at the distal end of the polypectomy device, therisk of unintentional trauma to the uterine wall is greatly reduced.This can be quite beneficial, particularly when such a device may beused by a doctor that does not typically specialize in uterine surgicalprocedures. Such a design may enable polypectomy is to be performed bygynecologists in their offices, as opposed to having to send a patientwith a polyp to the operating room.

One potential complication with performing uterine polypectomies in adoctor's office setting, as opposed to a hospital's surgical setting, isthat in-office procedures may not be reimbursed as much through a healthinsurance provider as the same or similar procedure performed in asurgical environment would be. For this and other reasons, such asgeneral efficiency, it can be desirable to reduce the complexity of apolyp removal device, thus also potentially reducing the cost of such adevice. If a polypectomy device as disclosed herein can be made at amore reasonable cost than heavier duty tools, such as fibroid removaltools, such a tool is more likely to be able to be used in the officesetting.

One feature of many of the embodiments disclosed herein that helps toreduce the complexity is that many of the embodiments disclosed hereincomprise an inner tubular member (or actuating member), such as theinner tubular member 114, that is configured to move with respect to theouter tubular member, such as outer tubular member 104, but only in onedegree of freedom. For example, some embodiments, such as thepolypectomy device 100 illustrated in FIG. 1A, allow the inner tubularmember to translate along the longitudinal axis with respect to theouter tubular member 104, but the inner tubular member 114 is notconfigured to move in any other direction, such as rotation about thelongitudinal axis. This is in contrast to the embodiment illustrated inFIG. 2A, which allows rotation, but not translation.

FIG. 2A illustrates an embodiment of a polypectomy device 200 that issimilar in many respects to the polypectomy device 100 of FIG. 1A. Thepolypectomy device 200 comprises a handle 202 an elongate outer tubularmember 204 extending from a distal end of the handle, and a distal end106 comprising two openings 108. In this embodiment, however, the innertubular member 214 is configured to rotate about a longitudinal axiswith respect to the outer tubular member 204, instead of translatingalong the longitudinal axis. To support this difference in movement, thehandle 202 is also of a different design than the handle 102. The handle202 comprises an actuating member 212 that rotates with respect to anonrotating portion 213. When the actuating member 212 rotates, itcauses the inner tubular member 214 to also rotate with respect to theouter tubular member 204, thus narrowing or closing the openings 108,enabling a polyp to be separated or removed from the uterine wall.

As noted above with respect to the polypectomy device 100, the actuatingmember 212 of the polypectomy device 200 may be designed differently.For example, in this case, the rotating portion 212 is directlyconnected to the inner tubular member 214 to cause rotation of the innertubular member 214 with respect to the outer tubular member 204.However, in other embodiments, the handle 202 may be designeddifferently and comprise various types of manual and/or automaticactuating mechanisms. For example, in some embodiments, a polypectomydevice comprises a more ergonomic grip shaped and configured to becomfortably held in a doctor's hand. The ergonomic grip may comprise anactuating member, such as a trigger, button, lever, or the like that ispositioned to be operated by, for example, the doctors index finger orthumb, or even all of the doctor's fingers at once.

Polypectomy Device in Use

FIG. 3 illustrates an example of a hysteroscope 300 that may be used inperforming a polypectomy along with the various embodiments ofpolypectomy devices disclosed herein. The hysteroscope 300 comprises anelongate member 307 having a working channel 301 passing therethrough.The working channel 301 can be sized to allow the outer tubular memberof a polypectomy device, such as the outer tubular member 104illustrated in FIG. 1A, to pass therethrough. The hysteroscope 300further comprises a visualization mechanism 303 that enables a doctor tosee within the uterine cavity. The hysteroscope 300 further comprises aplurality of ports 305. These ports 305 may be used to, for example,introduce or remove distention fluid from the uterus.

Although FIG. 3 illustrates one specific example of a hysteroscope 300,the polypectomy devices, methods, and systems disclosed herein may beused with any medical device that has a working channel for thepolypectomy device to be inserted therein. Further, in some embodiments,a polypectomy device may be used as a standalone medical instrument thatis not passed through the working channel of a scope or otherinstrument, and/or a hysteroscope or other medical instrument mayincorporate any of the one or more features of embodiments ofpolypectomy devices disclosed herein. For example, an alternativeembodiment of the hysteroscope 300 may comprise a distal endconfiguration having features similar to the distal ends of polypectomydevices disclosed herein that enable a polyp to be aspirated therein andseparated from the uterine wall.

FIG. 4 illustrates a schematic diagram of the polypectomy device 100 ofFIG. 1A in use with a patient and the hysteroscope 300 of FIG. 3. Inthis example, the hysteroscope 300, and specifically the elongatetubular member 307 of the hysteroscope 300, has been passed through thecervix 425 into the inner cavity 421 of the patient's uterus 420. Theouter tubular member 104 of the polypectomy device 100 has been passedthrough the working channel of the hysteroscope 300, causing the distalend 106 of the polypectomy device to extend into the cavity 421 of theuterus 420.

The schematic diagram of a uterus 420 illustrated in FIG. 4 comprises aplurality of polyps 422, 423 and a fibroid 424 attached to the uterinewalls. Although all fibroids and polyps are not the same size, thepresent diagram presents a relatively common size of fibroid 424 andpolyps 422, 423. It can be seen that the fibroid 424 is significantlylarger than the polyps 422, 423. Further, because of the toughness of afibroid as compared to polyps, it may be difficult and/or inefficient toremove the fibroid 424 using the present embodiment of a polypectomyremoval device 100. However, the present embodiment of a polypectomydevice 100 is ideally suited to remove the polyps 422, 423. Because ofthe relatively large openings 108 (as shown in FIG. 1B) of the distalend 106 of the polypectomy device 100, it is possible that a substantialportion of each of the polyps 422, 423, or even the entire polyp 422,423 may be aspirated into the polypectomy removal device at one time forseparation from the uterine wall. However, even if substantially all orthe entire polyp 422, 423 is not able to fit at one time into the distalend 106 of the polypectomy device 100, utilizing a relatively largeopening or openings can still make the process more efficient byincreasing the amount of tissue that may be removed at any one time overa device that has a smaller opening. Further, as mentioned above,various polypectomy devices disclosed herein are able to have such alarger opening because, among other things, the devices are intended toremove polyps, and not tougher tissue. Another reason is that variouspolypectomy devices disclosed herein are not intended to be insertedinto the body by puncturing tissue and making their own path into thebody, which can introduce relatively large stresses into the distal endof an instrument.

As can be seen in FIG. 4, polyps can be located at different portions ofthe uterus 420. For example, in this diagram, there are two polyps 422located on a side wall of the uterus, and there are two polyps 423located on a back wall of the uterus 420. Various embodiments ofpolypectomy devices disclosed herein can make it easier to reach andremove polyps in these various locations. For example, due to therelatively large openings 108 of the polypectomy device 100, thepolypectomy device 100 may be able to remove not only the side wallpolyps 422, but also the back wall polyps 423. However, as will bedescribed in greater detail below, other embodiments may be even bettersuited to easier removal of a back wall polyp 423. For example, theembodiment illustrated in FIG. 8A comprises an opening 808 that extendsthrough a distal tip of the distal end, thus making it even easier toposition the opening 808 adjacent to the back wall polyp 423.

The diagram illustrated in FIG. 4 further shows a collection system 430fluidly coupled to the vacuum port 116 and a vacuum source 432 fluidlycoupled to the collection system 430. The vacuum source 432 is furthercoupled to or comprises a vacuum control 434, such as, for example, afoot pedal, button, switch, trigger, and/or the like. The collectionsystem 430 can optionally be used with some embodiments to enablecollection of samples of removed polyps, such as for later analysis by alab. In some embodiments, the collection system 430 is a separate deviceor system that is fluidly coupled to the polypectomy device 100. Inother embodiments, a collection system may be integrated into thepolypectomy device. For example, as will be described in greater detailbelow with respect to FIG. 19B, a collection system may be integratedinto the handle portion of a polypectomy device.

Polyp Removal

FIGS. 5A-5C illustrate an example process for removing a uterine polypusing a polypectomy device as disclosed herein. Although the embodimentillustrated in FIGS. 5A-5C utilizes the polypectomy device 100 of FIG.1A, similar techniques may be used with different devices. Further,FIGS. 5A-5C focus on the operation of the distal end 106 of thepolypectomy device, and various modifications may be made to theproximal end, while still achieving the same or similar result.

With reference to FIG. 5A, in the present example, a doctor wants toremove a polyp 522 that is attached to a uterine wall 526. Accordingly,using the example polypectomy device 100 of FIG. 1A, the doctor mayensure the inner tubular member 114 is in the retracted position, thusfully opening the openings 108 to enable positioning therethrough of thepolyp 522. As can be seen in FIG. 5A, the bottom opening 108 has beenmaneuvered such that at least a portion of the polyp 522 has passedtherethrough. In some embodiments, positioning the polyp 522 through theopening 108 may be performed completely manually, meaning withoututilizing suction. However, in some embodiments, at least some suctionmay be activated to help draw the polyp 522 in through the opening 108.

Further, although this embodiment illustrates having the inner tubularmember or blade 114 in a fully retracted position, such that theopenings 108 are fully open at the start of the procedure, in otherembodiments, it may be desirable to at least partially advance the innertubular member 114 prior to insertion of the polyp 522 through theopening 108. For example, if suction is to be used to help aspirate thepolyp 522 into an opening 108, it may be desirable in some embodimentsto advance the inner tubular member 114 somewhat such as to narrow theopening 108 size, thus more narrowly concentrating the suction force. Asone of skill in the art will understand, for a given amount of suctionapplied to the polypectomy device, a smaller opening size 108 at thedistal end of the device will create a higher, more concentrated suctionforce than a larger opening 108. This is similar to the operation of anozzle, where a smaller orifice size in a nozzle will generate a higherpressure than a larger orifice size, even though the same quantity orsimilar quantity of fluid may be passing therethrough.

With reference to FIG. 5B, the inner tubular member or blade 114 is nowbeing advanced or extended in a distal direction toward the distal tip112 of the outer tubular member. The polyp 522, or at least a portion ofthe polyp 522, is positioned within the inner lumen of the inner tubularmember 114. With continued advancement of the inner tubular member 114and/or with continued or increased application of suction, the polyp 522will be separated from the uterine wall 526. With reference to FIG. 5C,the inner tubular member 114 has been advanced completely forward to thedistal tip of the polypectomy device, and the polyp 522 has beenseparated from the uterine wall 526. The polyp 522 can now continue tobe aspirated through the inner lumen of the inner tubular member 114, tothe left as oriented in FIG. 5C, and optionally collected within acollection system, such as the collection system 430 illustrated in FIG.4.

It should be noted that, although the inner tubular member 114 ispositioned completely forward or distally in FIG. 5C, in someembodiments, this may not imply that the inner tubular member 114 isfluidly sealed against the distal tip of the outer tubular member 104.In order to continue suction to cause the polyp 522 to pass through theinner lumen of the inner tubular member 114 after removal, it may bedesirable to have at least some fluid communication between theenvironment external to the polypectomy device, such as the uterinecavity, and the internal lumen of the inner tubular member 114. Thisfluid communication may occur in one or more of various ways, such as bya distal edge of the inner tubular member 114 not forming a completeseal against the distal end of the outer tubular member 104, the innertubular member 114 comprising a hole in its side wall that allowsdistention fluid to pass therethrough, the distal tip 112 of the outertubular member 104 comprising a hole, and/or the like. In someembodiments, a specific feature, such as a hole, is not necessarilyutilized to allow this certain amount of leakage or fluid communicationbetween the uterine cavity and the inner lumen of the inner tubularmember 114, but the manufacturing methods or tolerances of the inner andouter tubular members 114, 104 are such that a fluid-tight seal is notformed when the inner tubular member 114 is positioned in its fullyextended configuration.

Further, in some embodiments, even if a fluid-tight seal is formed whenthe inner tubular member 114 is at its distal most or fully extendedposition, this may be acceptable (or even desirable). For example, in acase where multiple polyps are being removed and/or where a polyp isbeing removed in multiple steps and not all at once, the doctor maycause the inner tubular member 114 to extend and retract multiple times.For example, the inner tubular member 114 may be extended to cut off aportion of a polyp, and then retracted to allow the next portion of thepolyp to be positioned through an opening 108 and within the inner lumenof the inner tubular member 114. The inner tubular member 114 may thenbe re-extended to separate that next portion of the polyp. Thisprocedure may be repeated as many times as desired or needed to removethe full polyp. In such a case, where the inner tubular member 114 isrepeatedly moved back and forth, even if the inner tubular member sealsor substantially seals against the outer tubular member 104 in the fullyextended position, there may be sufficient fluid communication when theinner tubular member 114 is in a non-fully extended position that polypsor pieces of polyps that have been removed will be able to betransferred through the inner lumen of the inner tubular member 114 andinto the collection system 430. Also, even in a case where a polyp isremoved in a single cut, it may be desirable for a doctor to be able tocontrol the amount of “leakage” of distention fluid into the innerlumen, such as by manipulating the actuating member of the handle.

Although the process illustrated in FIGS. 5A-5C illustrates an exampleof a polypectomy device removing a polyp with an inner tubular member114 that translates with respect to the outer tubular member 104,similar principles may be applied to polypectomy devices that comprisean inner tubular member that rotates with respect to the outer tubularmember. Various examples of such devices are described below.

It should be noted that, although various embodiments disclosed hereinare described as having a blade or cutting surface as part of an innertubular member, this should not be interpreted to mean that allembodiments comprise a cutting surface or cutting member integrallyformed with the inner tubular member. For example, with the embodimentillustrated in FIGS. 5A-5C, the most cost-effective way to create thatdevice may be to have a single inner tubular member that comprises thedistal cutting surface integrally formed at its distal end. However, insome embodiments, a distal portion (e.g., cutting member, cuttingportion, blade member, blade portion, and/or the like) may be coupled tothe inner tubular member and form the cutting surface or surfaces thatare used to cut a polyp. For example, it may be desirable to have anelongate inner tubular member formed of one material, and a cuttingportion formed of another material coupled to the end of the innertubular member. For example, an inner tubular member may comprise athin-walled stainless steel tube, and a cutting member comprising apolymer, composite, or other material may be coupled to the end of thestainless steel tube. This could, for example, enable the main elongateportion of the inner tubular member to be relatively thin and have arelatively large inner lumen, while enabling the distalmost cuttingmember or cutting portion to be relatively complicated in design and/orhave tighter tolerances than the rest of the inner tubular member. Anycutting member or other portion that is attached to the distal end ofthe inner or outer tubular member may be attached through variousmanufacturing methods, such as, for example, laser welding, adhesives,mechanical fasteners, and/or the like.

Distal End Configurations

Various configurations of the distal end of a polypectomy device (e.g.,the portion that protrudes from the working channel of a scope into theuterus) may be used with the embodiments disclosed herein. Some of thecommon features among many of these embodiments comprise an outertubular member and an inner tubular member, wherein the inner tubularmember is movable in at least one degree of freedom with respect to theouter tubular member. In many of the embodiments disclosed herein theouter tubular member is configured to be stationary with respect to thehandle of the device, and the inner tubular member is configured to movewith respect to the outer tubular member and handle. However, someembodiments may be configured to move the outer tubular member withrespect to the handle and inner term tubular member, while keeping theinner tubular member fixed with respect to the handle. Further, someembodiments may be configured to move both the outer and inner tubularmembers with respect to the handle and with respect to one another.

Further, various embodiments disclosed herein, as mentioned above, areconfigured to have one degree of freedom between the inner and outertubular members. Specifically, many of the embodiments disclosed hereinare configured to have the inner tubular member be translatable along alongitudinal axis with respect to the outer tubular member, or rotatableabout the longitudinal axis with respect to the outer tubular member,but not both. Some embodiments, however, may include both rotation andtranslation of the inner tubular member with respect to the outertubular member.

It should be noted that, when the present disclosure refers to tubularmembers, namely the outer tubular member and inner tubular member, thisis not intended to restrict the embodiments disclosed herein to aconfiguration where the inner and/or outer tubular member comprises acylindrical or annular shape along its entire length. Rather, the termtubular member is intended to refer to a member of the polypectomydevice that comprises at least an outer wall that extends in alongitudinal direction and forms a lumen defined by an inner surface ofthe member. In many embodiments, the tubular members are cylindrical orannular in shape, at least for a significant portion of their length. Itis envisioned, however, that some embodiments could include anon-cylindrical shape for the inner and/or outer tubular members.Further, although in some embodiments the inner and outer tubularmembers may comprise a generally cylindrical or annular shape along amajority of their length (e.g., the central portion that is intended tobe positioned within a working channel of a scope or other medicalinstrument), the shape or configuration of the tubular members may bedifferent at the distal end of the polypectomy device, where theopenings for insertion therethrough of polyps are located, and/or at theproximal end, where the inner and outer tubular members interface withthe handle.

Described below are various embodiments of distal end configurations.Each of these distal end configurations may be used with a variety ofpolypectomy device designs, including polypectomy devices havingdifferent shapes and configurations of handles, polypectomy deviceshaving integrated vacuum suction and/or polyp collection features,polypectomy devices without integrated suction and/or collectionfeatures, manually operated polypectomy devices, electrically,pneumatically, or hydraulically operated polypectomy devices, and/or thelike. Further, these various distal end configurations may be integratedinto a different medical device, such as a hysteroscope, other scopedevice, and/or the like.

In some embodiments, the various distal end configurations disclosedherein are integrally formed into the inner and/or outer tubularmembers. For example, a cylindrical tube may have one or more openingsor other features cut into it to form the distal end configuration. Insome embodiments, however, the distal end configurations may be formedby joining one or more separate components to the inner and/or outertubular members. For example, to form a blunt rounded tip of the outertubular member, a blunt rounded portion may be attached to the end ofthe outer tubular member, such as via laser welding, adhesives, and/orother affixation methods. Further, the inner tubular member may comprisea substantially cylindrical or annular elongate portion that has a bladeor cutting portion affixed to its distal end, with that affixed blade orcutting portion being the portion that mechanically contacts the polypto help separate the polyp from the uterine wall.

It should also be noted that, as discussed in greater detail below,although portions of polypectomy devices disclosed herein are describedas having a blade, cutting feature, and/or the like, this is notnecessarily intended to imply that the blade, cutting portion, and/orthe like is sharpened. As mentioned above, because polyps are generallyof a relatively gelatinous consistency, a “blade” configured to separatea polyp from the uterine wall may not need to be sharpened, and maycomprise a blunt edge. This can have multiple benefits. For example,risk of unintentional trauma to the uterine wall can be reduced byhaving an unsharpened edge of the blade or cutting surface. Further,manufacturing costs may be reduced if a sharpening operation does notneed to be performed to create the cutting surface. This can furtherhelp to bring the cost of such a polypectomy device down to the pointthat it is practical for use in doctor's office setting, as opposed to ahospital surgical setting.

In various embodiments, various materials may be used to form the innerand/or outer tubular members of a polypectomy device disclosed herein.For example, the inner and/or outer tubular members may be formed fromsurgical grade stainless steel tubing. Other materials may also be used,however, such as, for example, liquid crystal polymer tubing. Further,in some embodiments, the inner and/or outer tubes are composite designs,meaning two or more materials may be joined together to form the finalcomponent. For example, the inner and/or outer tubular members may beformed from stainless steel tubing that forms a majority of the elongateportion of the tubular member, but a different material, such as apolymer, carbon fiber, composites, and/or the like, may be used to formthe distal end that comprises the opening or openings for the polyp topass therethrough and/or the blade/cutting surface. These differentmaterials may be coupled together using various manufacturer practices,such as laser welding, friction welding, adhesives, fasteners, and/orthe like.

Following are descriptions of several groups of figures which illustratevarious embodiments of distal end configurations of polypectomy devicesas disclosed herein. The different configurations can generally begrouped into two types of configurations, namely, translating orrotating. As mentioned above, to maintain relative simplicity inmanufacturing and operation, and to keep manufacturing costs down, itcan be desirable to design a polypectomy device that operates using arelatively simple mechanical actuation, such as translation of the innertubular member or rotation of the inner tubular member, but not both. Itshould be noted, however, that various other embodiments of polypectomydevices as disclosed herein may comprise more than one degree of freedomin the actuation.

FIGS. 6A-6E illustrate an embodiment of a distal end configuration thatutilizes a translating inner tubular member 114. The embodimentillustrated in FIGS. 6A-6E provides additional details of the designintroduced in FIGS. 1A and 1B. With reference to FIG. 6B, the innertubular member 114 comprises a substantially cylindrical tube nestedconcentrically inside of a substantially cylindrical outer tubularmember 104. The outer tubular member 104 comprises two openings 108positioned opposite one another. The two openings 108 are separated bytwo supporting arms 110, also positioned opposite one another.

It can be beneficial in some embodiments to have more than one opening108, such as is shown in the present embodiment to, among other things,enable removal of polyps that are located in various locations of theuterine cavity without requiring excessive rotation of the outer tubularmember 104 and the handle attached thereto. For example, in anembodiment that comprises a pistol grip type handle, similar to asdescribed below with reference to FIGS. 18A and 18B, it may be desirableto have the pistol grip handle oriented such that it is pointed directlydownward or not too far away from being pointed downward. For example,it may be desirable to use the tool with the pistol grip handle pointingdownward or within 45° clockwise or counterclockwise from directlydownward. With a configuration as illustrated in FIGS. 6A-6E, it islikely that a doctor will be able to reach all or nearly all polyps thatmay need to be removed without needing to rotate the handle outside ofthat 90° range.

In some embodiments, the outer tubular member 104 may be rotatable alongthe longitudinal axis with respect to the handle. This may, for example,enable selective angular positioning of the opening(s) 108 withouthaving to rotate the entire handle. For example, a knob or wheelconnected to the handle may allow a doctor to rotate the outer tubularmember with respect to the handle.

FIG. 6D is a cross sectional end view that provides additional detail asto the shape and size of the openings 108. Since these openings 108 arepositioned opposite one another it can be considered that radial orangular midpoints of the two openings 108 are positioned 180° from oneanother. In some embodiments, that angle may be different. For example,the relative orientation of midpoints of the two openings 108 may be,for example, exactly, about, no more than, or no less than 180°, 170°,160°, 150°, 140°, 130°, 120°, 110°, 100°, or 90°. As the relativeangular position of the openings 108 with respect to each other isreduced, there will become a point, depending on the size of theopenings 108, that the size of the openings may need to be decreased orone of the supporting arms 110 between the openings would go away andthe two openings would merge into a single opening.

With further reference to FIG. 6D, the outer tubular member 104comprises an outer diameter 631, and the inner tubular member 114comprises an outer diameter 632. The outer diameter 632 may besufficiently smaller than an inner diameter of the outer tubular member104, to enable translating or sliding motion of the inner tubular member114 with respect to the outer tubular member 104. The inner tubularmember 114 further comprises an inner diameter 633. It can be desirableto have the inner diameter 633 be as large as possible, such as toenable easy passage of relatively large polyps or pieces of polyps thathave been removed.

This and other embodiments disclosed herein may utilize various sizes oftubing in manufacturing the polypectomy devices. For example, the outertubular member 104, and/or various other outer tubular members disclosedherein, may comprise in some embodiments an outer diameter 631 of 0.12inches and a wall thickness of 0.01 inches. This leads to a nominalinner diameter of 0.10 inches. Further, the inner tubular member 114,and/or various other inner tubular members disclosed herein, maycomprise in some embodiments an outer diameter 632 of 0.095 inches witha material thickness or wall thickness of 0.0065 inches. This creates anominal inner diameter 633 of 0.082 inches. The size of the outertubular member 104 may correspond to standard hypodermic tubing of gauge11 TW.

In various embodiments, various other tubing sizes may be used for theinner and outer tubular members, depending on, among other things, thesize of the scope working channel through which the outer tubular memberis intended to be inserted, the size of the openings 108 in the distalend of the tubing, the expected stresses the tubing will be subjected toin use, the torsional stresses needing to be transferred through arotating inner tubular member, and/or the like. For example, the outerdiameters 631 and 632 of the outer and inner tubular members,respectively, in any of the embodiments disclosed herein may beapproximately, exactly, no greater than, or no less than 0.203 inches,0.188 inches, 0.180 inches, 0.172 inches, 0.165 inches, 0.156 inches,0.148 inches, 0.141 inches, 0.134 inches, 0.126 inches, 0.120 inches,0.115 inches, 0.109 inches, 0.1 inches, 0.095 inches, 0.089 inches,0.083 inches, 0.078 inches, 0.072 inches, 0.068 inches, 0.065 inches,0.062 inches, 0.059 inches, 0.058 inches, or 0.050 inches, correspondingto 6 through 18 gauge hypodermic tubing sizes. Further, in any of theembodiments disclosed herein, the outer and/or inner tubular members'wall thicknesses may be approximately, exactly, no greater than, or noless than 0.015 inches, 0.014 inches, 0.013 inches, 0.012 inches, 0.011inches, 0.010 inches, 0.009 inches, 0.008 inches, 0.007 inches, 0.006inches, 0.005 inches, 0.004 inches, 0.003 inches, or 0.002 inches, alsocorresponding to 6 through 18 gauge hypodermic tubing sizes. Desirably,the outer diameter 632 of the inner tubular member is slightly smallerthan the inner diameter of the outer tubular member, to enable slidingand/or rotational relative motion.

The openings 108 also comprise a plurality of dimensions defining theirshape. The openings 108 comprise a longitudinal length 634, a transversewidth 635, and an angular opening size or width 636. The longitudinallength 634 is measured in the longitudinal direction from the radialoutermost edge of the outer tubular member 104. The width 635 ismeasured in the transverse direction from the radially innermost edge ofthe outer tubular member 104, at approximately a longitudinal midpointof the openings 108, as shown in the cross-section of FIG. 6D.Similarly, the angular width 636 is measured from the innermost radialedge of the outer tubular member 104, at approximately a longitudinalmidpoint of the openings 108, as shown in the cross-section of FIG. 6D,with reference to the centerline or longitudinal axis of the outertubular member 104. The supporting arms 110 also comprise a transversewidth 637, measured at approximately a longitudinal midpoint of theopenings 108, as shown in the cross-section of FIG. 6D.

In this embodiment, the longitudinal length 634 is desirablyapproximately 10 mm, the transverse width 635 is desirably approximately2.138 mm, and the transverse width 637 of the arms is desirablyapproximately 1.37 mm. Other dimensions may be used in this and otherembodiments, however. For example, it may be desirable for the length634 of the openings 108 to be longer, such as to enable insertiontherethrough of a larger portion of a polyp, or to be shorter, such asto make the design stiffer or more robust, or to cut smaller portions ofpolyps to help prevent clogging. For example, in various embodiments,the length 634 of the opening 108 may be approximately, exactly, nogreater than, or no less than, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm,10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or20 mm. Further, the width 637 of the arms 110, related to the radialdepth of the openings 108, may vary in various embodiments based on, forexample, the desirable size of the opening and/or the desired robustnessof the design. For example, in some embodiments, the width 637 of thearms 110 may be approximately, exactly, no greater than, or no lessthan, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm,1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm,2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, or 3.0mm. Further, the transverse width 635 of the openings 108 may be variedin various embodiments based on, for example, the desirable size of theopenings and/or the desired robustness of the design. For example, insome embodiments, the width 635 may be approximately, exactly, nogreater than, or no less than, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm,2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm,2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, or 3.5 mm. Further, theangular width 636 of the openings 108 may vary in different embodimentsbased on, for example, the desirable size of the opening and/or thedesired robustness of the design. For example, in some embodiments, theangular width 636 of the openings 108 may be approximately, exactly, nogreater than, or no less than, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°,70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°,135°, 140°, 145°, 150°, 155°, 160°, 170°, 180°, 190°, 200°, 210°, 220°,230°, 240°, 250°, 260°, or 270°. In some embodiments, the number ofopenings 108 may be more or less, depending on, among other things, theangular width 636 of each of the openings. For example, as the angularwidth 636 approaches 180°, the device may be limited to a singleopening, or a second or additional openings may need to have an angularwidth 636 substantially less than 180°, to leave room for supportingarms 110. On the other hand, as the angular width 636 becomes less than120°, the polypectomy device may be able to have three or more openings108. Further, in various embodiments, the two or more openings 108 donot have to comprise the same nominal dimensions. For example, oneopening may be longer and/or wider than another.

In various embodiments, the opening length 634 versus width 635 may bevarious ratios. For example, in the present embodiment, the ratio isapproximately 4.7. In other embodiments, it may be desirable to have asmaller ratio, such as approximately, exactly, no greater than, or noless than 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, or 4.5. In otherembodiments, it may be desirable to have a larger ratio, such asapproximately, exactly, no greater than, or no less than 5.0, 5.5, 6.0,6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, or 10.0.

As mentioned above, because the embodiments disclosed herein areintended to remove polyps, and not necessarily tougher body tissue, suchas fibroids, the openings 108 of the present embodiment, or similaropenings in various other embodiments disclosed herein, may berelatively large in comparison to the size and/or thickness of thetubing through which the opening is cut. This is because the expectedstresses, such as bending or torsional stresses, may be lower than ifthe tool were intended to cut or remove tougher tissue. For example,with reference to the embodiment of FIGS. 6A-6E, the length 634 of theopenings 108 is approximately 10 mm, and the outer diameter 631 of theouter tubular member 104 is approximately 3.048 mm, or 0.12 inches.Accordingly, the nominal ratio of opening length to outer tubular memberouter diameter is approximately 3.28. In various embodiments, includingthe present embodiment and the various other embodiments disclosedherein, the ratio of longitudinal length of an opening in the outertubular member to the outer diameter of the outer tubular member can beapproximately, exactly, no greater than, or no less than, 1.0, 1.5, 2.0,2.5, 3.0, 3.28, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, or 8.0.This relatively large opening with respect to the size of the outertubular member may also be defined as a ratio of the longitudinal length634 of the opening 108 with respect to the wall thickness of the outertubular member. For example, the present embodiment comprises alongitudinal length 634 of the opening 108 of approximately 10 mm, or0.394 inches, and an outer tubular member wall thickness ofapproximately 0.01 inches. Accordingly, the nominal ratio of openinglength to outer tubular member wall thickness is approximately 39.4. Invarious embodiments, including the present embodiment and various otherembodiments disclosed herein, the ratio of longitudinal length of anopening in the outer tubular member to the wall thickness of the outertubular member can be approximately, exactly, no greater than, or noless than, 20, 25, 30, 35, 39.4, 40, 45, 50, 55, 60, 65, 70, 75, or 80.

This relatively large opening with respect to the size of the outertubular member may also be defined as a ratio of the transverse width635 of the opening 108 with respect to the outer diameter 631 of theouter tubular member. For example, the present embodiment comprises atransverse width 635 of the opening of approximately 2.138 mm, or 0.084inches, and the outer diameter 631 of the outer tubular member isapproximately 0.12 inches. Accordingly, the nominal ratio of transversewidth of the opening with respect to the outer diameter of the outertubular member is approximately 0.7. In various embodiments, includingthe present embodiment and various other embodiments disclosed herein,the ratio of transverse width of the opening to the outer diameter ofthe outer tubular member can be approximately, exactly, no greater than,or no less than, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 0.9. Because thetransverse width 635 may be somewhat dependent on the outer tube wallthickness, particularly with higher ratios, a smaller tube thickness maybe desirable as the ratio increases. Further, this relatively largeopening with respect to the size of the outer tubular member may also bedefined as a ratio of the transverse width 635 of the opening 108 withrespect to the wall thickness of the outer tubular member. For example,the present embodiment comprises a transverse width 635 of the openingof approximately 2.138 mm, or 0.084 inches, and the wall thickness ofthe outer tubular member is approximately 0.01 inches. Accordingly, thenominal ratio of transverse width of the opening with respect to thewall thickness of the outer tubular member is approximately 8.4. Invarious embodiments, including the present embodiment and various otherembodiments disclosed herein, the ratio of transverse width of theopening to the wall thickness of the outer tubular member can beapproximately, exactly, no greater than, or no less than, 5, 6, 7, 8,8.4, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20.

This relatively large opening with respect to the size of the outertubular member may also be defined as a percentage of the circumferenceof the outer tubular member that is cut away (e.g., removed or otherwisenot present), forming openings therethrough. For example, with referenceto the cross-sectional view shown in FIG. 6D, this embodimentillustrates an example where the outer circumference of the outertubular member 631 is greater than 50% cut away to form the two openings108, and thus less than 50% of the outer circumference remains to formthe supporting arms 110. It can be desirable in some embodiments tomaximize the percentage of the outer circumference of the outer tubularmember that is cut away to form one or more openings through the outertubular member, while leaving enough material to sufficiently resist anyexpected bending and/or torsional stresses that will be applied to theouter tubular member. In some embodiments, the outer circumference ofthe outer tubular member, at a longitudinal location approximatelycentered in the one or more openings 108, is approximately, exactly, nogreater than, or no less than, 30%, 40%, 50%, 60%, 70%, or 80% cut awayto form the one or more openings 108.

The various dimensions and ratios given herein that help to define thebounds of the size of the opening or openings with respect to the outertubular member may be used with any of the embodiments disclosed herein,even though the specific shape of the openings in other embodiments maybe somewhat different in some other embodiments. For example, thedimensions and ratios given with respect to the longitudinal length 634may also apply to longitudinal length 840 shown in FIG. 8E, alongitudinal length of the opening 908 illustrated in FIG. 9F,longitudinal length 1040 of FIG. 10B, longitudinal length 840 of FIG.14E, and the like. As another example, the dimensions and ratios givenwith respect to the transverse width 635 of the opening may also applyto a transverse width of opening 808 of FIG. 8A, a transverse width ofopening 908 of FIG. 9A, a transverse width of opening 1008 of FIG. 10A,a transverse width of opening 1408 of FIG. 14A, and the like. Further,the percentages given above of the outer circumference of the outertubular member that are cutaway to form one or more openings may applyto various other embodiments, such as the embodiments illustrated inFIG. 7E, FIG. 8F, FIG. 9G, FIG. 10D, FIG. 11D, FIG. 14F, and the like.

FIG. 6E is a detail view of the cross-section shown in FIG. 6B, whichshows enlarged detail of the distal end of the inner tubular member 114,which acts as a blade or cutting surface. As mentioned above, it can bedesirable in polypectomy devices disclosed herein to utilize a blade orcutting surface that is not actually sharpened as a blade typicallywould be. This can promote safety and also reduce manufacturing costs.As can be seen in FIG. 6E, the distal end of the inner tubular member114 in this embodiment does comprise a chamfered or beveled edge definedby angle 640. However, unlike a design where a sharp edge is desired,the chamfered or beveled edge does not extend through the outer radialedge of the inner tubular member 114, thus leaving a blunt distalcutting surface 652 having transverse width 641. In this embodiment,width 641 is approximately 0.04 mm. In other embodiments, however, thewidth 641 may be larger, smaller, or may even be the full width of thematerial (e.g., if there is no chamfer). The cutting surface 652 ispositioned to cooperate with opposing cutting surfaces 653 of the outertubular member in cutting polyps. Additional examples of cutting edge orsurface configurations, dimensions, and ratios are given below withreference to FIGS. 15A-15C.

FIGS. 7A-7E illustrate a distal end configuration embodiment having somesimilarities to the embodiment illustrated in FIGS. 6A-6E, except thatthe inner tubular member 214 is configured to rotate instead oftranslate. In this embodiment, the outer tubular member 204 is similarin design to the outer tubular member 104 of FIGS. 6A-6E, and theopposing openings 108 in outer tubular member 204's distal end aresimilar to those in FIGS. 6A-6E. Accordingly, the same reference numbershave been used with respect to the openings 108, and the description,dimensions, and ratios given above with respect to FIGS. 6A-6E can alsoapply to the design illustrated in FIGS. 7A-7E.

One difference in the embodiment illustrated in FIGS. 7A-7E is that theinner tubular member 214 comprises a protruding member 750 that extendslongitudinally in a distal direction. The protruding member 750comprises a cutout or opening 751 which, depending on the instant radialorientation of the inner tubular member 214 with respect to the outertubular member 204, allows a polyp to be aspirated in through an outeropening 108 and the cutout 751, and into the inner lumen of the innertubular member 214. In this embodiment, instead of using a distal endface as a cutting surface, such as the face or surface 652 shown in FIG.6E, the protruding member 750 comprises cutting surfaces 752 positionedopposite one another and positioned to separate a polyp from the uterinewall when the cutting surfaces 752 approach the edges 753 of thesupporting arms 110 of the outer tubular member 204. As the innertubular member 214 rotates, the radial movement of the cutting edges 752causes an effective opening size (e.g., the size of the combined openingfrom an external environment into the inner lumen of the inner tubularmember created by the relative orientation of the inner and outertubular members) of the one or more openings 108 to vary. For example,with reference to FIG. 7A, the effective opening size 708 isapproximately 50% of the full opening size 108 in the presentorientation. If the inner tubular member 214 were rotated 90° from thisposition, one of the openings 108 would be fully open into the innerlumen of the inner tubular member, and the other opening 108 would befully blocked from the inner lumen by the protruding member 750.

As the inner tubular member 214 rotates and reduces the effectiveopening size 708, a polyp that is positioned there through is eventuallypinched off and separated from the uterine wall. As with various otherembodiments, the surfaces or edges 752 and/or the sides 753 of thesupporting arms 110 which pinch off the polyp do not necessarily need tobe sharpened, due to the generally gelatinous consistency of polyps.

With reference to FIGS. 7B and 7E, the cutout or opening 751 in thisembodiment comprises a longitudinal length 740 and a radial depth 742.Further, the cutout 751 comprises an angular width 744 as shown in FIG.7E. In this embodiment, the angular width 744 is desirably 180°, meaningapproximately half of the distal end of the inner tubular member 214 hasbeen “cut away.” In various embodiments, however, the angle 744 may bemore or less than 180°. For example, the angle 744 may be, about,substantially, no more than, or no less than, 90°, 100°, 110°, 120°,130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°,250°, 260°, or 270°.

In this embodiment, the longitudinal length 740 of opening or cutout 751is approximately 11.6 mm, and the radial or transverse depth 742 of thecutout or opening 751 is approximately 1.2 mm. Further, the outerdiameter of the inner tubular member 214 is approximately 2.4 mm or0.095 inches, with a tubing wall thickness of approximately 0.229 mm or0.009 inches. Similarly to as discussed above with reference to openings108, the cutout or opening 751 can be a relatively large size withrespect to the size and/or thickness of the inner tubular member 214,given that the medical instrument is intended to remove polyps and notnecessarily tougher material, such as fibroids.

As with the openings in the outer tubular member, the opening or cutout751 in the inner tubular member may comprise various dimensions andratios. For example, the length 740 of the cutout 751 may be describedas a ratio versus the outer diameter or wall thickness of the innertubular member 214. For example, the present embodiment comprises alength 740 of approximately 11.6 mm or 0.457 inches and an outerdiameter of the inner tubular member 214 of approximately 0.095 inches,giving a ratio of about 4.8. In various other embodiments, includingembodiments similar to as shown in FIG. 7B or in any other embodimentsherein, this ratio may be different, such as approximately, exactly, nogreater than, or no less than, 1, 2, 3, 4, 4.8, 5, 6, 7, 8, 9, or 10. Asa ratio of cutout length 740 to material thickness of the inner tubularmember, the present embodiment comprises a length 740 of approximately0.457 inches and a tubular wall thickness of approximately 0.009 inches,giving a ratio of approximately 50.8. In other embodiments, this ratiomay be larger or smaller, such as approximately, exactly, no greaterthan, or no less than, 10, 15, 20, 25, 30, 35, 40, 45, 50, 50.8, 55, 60,65, 70, 75, 80, 85, 90, 95, or 100. Further, the depth 742 of the cutout751 in the present embodiment is approximately 50% of the outer diameterof the inner tubular member 214. In some embodiments, the depth 742 ofthe cutout 751 can be more or less, such as exactly, approximately, nogreater than, or no less than, 20%, 30%, 40%, 50%, 60%, 70%, or 80%. Ingeneral, a lower percentage will lead to a more rigid design but smalleroverall opening 751. On the other hand, a higher percentage will lead toa less rigid design but larger overall opening 751.

With respect to absolute dimensions, the length 740 of the cutout 751may in other embodiments comprise various other lengths, such as, forexample, approximately, exactly, no greater than, or no less than, 3 mm,4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 11.6 mm, 12 mm, 13 mm,14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. Further, the depth742 of the cutout 751 may comprise various depths, such as, for example,approximately, exactly, no greater than, or no less than, 0.3 mm, 0.4mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, or 3.0 mm.In general, as the outer diameter of the inner tubular member isincreased, the depth 742 of the cutout 751 may also be increased whilemaintaining a same or similar level of torsional or bending stiffness.

The dimensions and ratios given herein with respect to cutout 751 mayalso apply to other embodiments, such as the cutout 751 shown in FIG.8C, or the cutout in inner tubular member 1414 shown in FIG. 14E.

FIGS. 8A-8F illustrate another embodiment of a distal end configurationthat utilizes relative rotation of the inner tubular member 214 withrespect to outer tubular member 804 to separate polyps from a uterinewall. In this embodiment, the inner tubular member 214 is similar indesign to the inner tubular member 214 illustrated in FIGS. 7A-7E.Accordingly, similar reference numbers are used, and the descriptionsand various dimensions and ratios described above with reference toFIGS. 7A-7E also apply to the inner tubular member 214 of FIGS. 8A-8F.One difference in the embodiment illustrated in FIGS. 8A-8F is that theouter tubular member 804 is different than the outer tubular member 204of FIGS. 7A-7E. In this embodiment, the outer tubular member 804comprises a single opening 808 which is similar in design to the cutoutor opening 751 of the inner tubular member 214. Instead of having twosupporting arms 110 that separate two openings 108, the outer tubularmember 804 comprises a single protruding member 850 having an opening orcutout 808 similar to the opening or cutout 751 of the inner tubularmember 214.

In operation, the inner tubular member 214 is caused to rotate withrespect to the outer tubular member 804, and the blades or cutting edgesor surfaces 752 and 852 are caused to approach one another andeventually come together to close the effective opening 808. As theblades or cutting surfaces 752, 852 approach one another, a polyp iscaused to be pinched off and separated from the uterine wall.

Similar to the cutout or opening 751, the cutout or opening 808 of theouter tubular member 804 comprises a longitudinal length 840, a radialdepth 842, and an angular width 844. In this embodiment, the angularwidth 844 is desirably 180°, which is identical to the angular width 744of the cutout 751 of the inner tubular member 214. In some embodiments,it can be desirable to have angular width 844 of the opening in theouter tubular member 804 be larger or smaller. For example, if theangular width 844 of the opening 808 is smaller than 180°, and theangular size of the opening in the inner tubular member 744 is largerthan the angular size of the opening in the outer tubular member, thenthe protruding member 750 of the inner tubular member 214 will beconstrained by the protruding member 850 in the transverse or radialdirection as it rotates. This may help to resist any bending momentsthat may be placed on the distal tip of the protruding member 750 duringcutting of a polyp. However, if the angular size 844 of the opening 808of the outer tubular member 804 is only slightly less than 180°, it ispossible the protruding member 750 of the inner tubular member 214 maybecome jammed in the opening 808, due to manufacturing tolerances and/orelastic bending of the protrusion 750 during use. Accordingly, if it isdesired in a particular embodiment to have the angular opening size 844of the opening 808 be less than 180°, it can be desirable to make surethat angle is sufficiently smaller than 180° that jamming of theprotruding member 750 is unlikely to occur, taking into accountmanufacturing tolerances and anticipated bending moments that may beapplied to the protruding member 750.

The shape and size of the cutout or opening 751 can have the same orsimilar dimensions 740, 742 as described above with reference to FIG.7B. Further, the opening 808, having corresponding dimensions 840 and842, may comprise similar dimensions to the cutout 751, but scaled up toa larger diameter tubing. For example, in this embodiment, the length840 and length 740 are both the same, being approximately 10 mm. In someembodiments, however, the lengths of the two openings may be different.The same absolute lengths and ratios of length to tubing diameter and/ortubing thickness can apply to the length 840 with respect to the outertubular member as described above for length 740 with respect to theinner tubular member. Further, the same dimensions and ratios asdiscussed above with respect to depth 742 can apply to depth 842 of FIG.8E, but with respect to the outer tubular member instead of the innertubular member.

FIGS. 24A-24C illustrate an alternative embodiment of an inner tubularmember 2414 that can replace inner tubular member 214 of the embodimentillustrated in FIGS. 8A-8F. Similar reference numbers are used toreference features that are similar to or the same as the embodimentillustrated in FIGS. 8A-8F. One difference with the inner tubular member2414 versus the inner tubular member 214 is that the longitudinal length740 of the opening 751 is shorter in this embodiment. For example, thisembodiment may comprise a length 740 of approximately 5 mm, instead of10 mm. Any of the various other dimensions given above with respect tolongitudinal length 740 may also apply to this embodiment, however.

Another difference with the embodiment illustrated in FIGS. 24A-24C isthat the cutout or opening 751 does not comprise a substantially flatU-shaped cutting surface 752, as in the embodiment illustrated in FIGS.8A-8F. Rather, with reference to FIGS. 24A and 24B, the inner tubularmember 2414 comprises a cutout 751 defined at least in part by twosurfaces 752 on transversely opposite sides of the cutout 751, thecutting surfaces 752 extending in a direction parallel to thelongitudinal axis of the inner tubular member 2414. At the distal tip ofthe cutout 751, however, the cutting surface rises or extends upwardfrom the cutting surfaces 752 to form a raised lip or additional cuttingedge 2452.

This raised lip or cutting edge 2452 positioned at the distal tip of theinner tubular member 2414 can provide multiple benefits. For example, insome embodiments, such as in an embodiment where the angular widths 744and 844 of the openings in the inner and outer tubular members are both180 degrees, the lip 2452 can stop the inner tubular member 2414 frombeing able to translate distally in a longitudinal direction withrespect to the outer tubular member when the opening 808 is in acompletely closed configuration (e.g., the protruding members 750 and850 are positioned rotationally opposite one another). If the protrudingedge or lip 2452 were not present (for example, as with the embodimentshown in FIGS. 8A-8F), it may potentially be possible for the protrudingmember 750 of the inner tubular member to translate distally beyond theprotruding number 850 of the outer tubular member (e.g., to slide pastthe protruding member 850) when the inner tubular member is oriented atan angular position that is 180° from the position illustrated in FIG.8F, which could, for example, stop the inner tubular member from beingable to rotate. Note that this is assuming the inner tubular member isnot otherwise restricted or restrained from translating longitudinallywith respect to the outer tubular member. In some embodiments, however,the inner tubular member may be restricted, at least somewhat, in thelongitudinal direction with respect to the outer tubular member by, forexample, the connection of the inner tubular member to the handle of thedevice. However, given the relatively small size of such a medicaldevice, and the tolerances inherent in manufacturing processes, it maybe desirable to have the inner tubular member 2414 be biased in a distaldirection with respect to the outer tubular member 804, such as by aspring or other feature located in the handle or elsewhere, and to havethe distal tip of the protruding member 750 pressing against an interiordistal tip surface of the protruding member 850 be the mechanicalfeature that limit distal longitudinal translation of the inner tubularmember with respect to the outer tubular member. This can help to keepthe cutting edge 2452 as close as possible to the corresponding cuttingedge or surface 852 in the distal tip of the outer tubular member, thusincreasing cutting efficiency. This can be analogous to scissors, where,if the two cutting edges are kept tightly against one another, cuttingcan be relatively efficient; however, if there is slop between the twocutting edges, cutting efficiency can drop.

Another benefit of the protruding member 750 of FIGS. 24A-24C comprisingthe lip or protruding cutting edge 2452 is that the cutting edge 2452may more efficiently cut or shear polyp tissue that is positioned at orthrough the distal tip of the opening 751 than the design shown in FIG.8B, where two semicircular edges come together at the distal tip. Insome embodiments, the outer tubular member may additionally oralternatively comprise a raised lip or cutting edge similar to theraised lip or cutting edge 2452 of the inner tubular member. With thelip 2452 of the inner tubular member, the lip 2452 desirably comes to apoint or edge positioned at a distal (or outer) side of the materialthat forms the rounded distal tip of the protruding member 750. If theprotruding member 850 of the outer tubular member comprises a similarlip, it would desirably come to a point or edge positioned at a proximal(or inner) side of the material that forms the rounded distal tip of theprotruding member 850, since that is the side of the material that wouldinterface with the inner tubular member.

In this embodiment, the cutting edge or lip 2452 comprises a height 2442with respect to transverse surfaces 752. This height 2442 may comprisevarious sizes in various embodiments. For example, height 2442 may beexactly, approximately, no more than, or no less than, 0.005 inches,0.006 inches, 0.007 inches, 0.008 inches, 0.009 inches, 0.010 inches,0.011 inches, 0.012 inches, 0.013 inches, 0.014 inches, 0.015 inches,0.020 inches, 0.025 inches, 0.030 inches, 0.035 inches, 0.040 inches,0.045 inches, or 0.050 inches. In some embodiments, a ratio of theheight 2442 of the lip to the height 742 of the cutout may be exactly,approximately, no more than, or no less than, 0.1, 0.2, 0.3, 0.4, or0.5. In some embodiments, the raised edge or lip 2452 is formed with agradual radiused profile 2443 shown in the side view of FIG. 24B. It canbe desirable to have such a radiused profile 2443 to, for example, makethe tip or lip 2452 more durable and/or resisting of deformation. Insome embodiments, the profile 2443 may be of a different shape, such as,for example, a ramp, a radius of a smaller or larger size, and/or thelike.

FIGS. 9A-9G illustrate another example distal end configurationembodiment that utilizes translation of the inner tubular member 914with respect to outer tubular member 904 to separate polyps from theuterine wall. In this embodiment, the outer tubular member comprises anopening 908 positioned on a distal end side wall of the outer tubularmember 904. In this embodiment, the opening 908 is substantiallyrectangular in shape. However, in other embodiments, the opening 908 maybe shaped differently, and/or more than one opening 908 may be includedat different angular locations about the outer tubular member 904 and/orat different longitudinal locations.

In this embodiment, the outer tubular member 904 further comprises anopening 952 at its distal end tip. This opening 952 allows a bluntrounded tip 950 of the inner tubular member 904 to pass therethrough.One benefit of this configuration is that it enables the opening 908 tobe positioned longitudinally relatively close to the end face or surface964. In this embodiment, the distalmost portion of the opening 908 ispositioned a longitudinal distance 960 from the end face 964. Thislength 960 is desirably equal to or greater than the longitudinal length940 of the opening or cutout 951 in the inner tubular member 914.

In the present embodiment, the length 940 of opening 951 isapproximately 0.08 inches, the length 962 of opening 908 isapproximately 0.094 inches, and the length 960 that defines the positionof the distalmost edge of opening 908 is approximately 0.088 inches. Inother embodiments, these dimensions may be different. For example, thelength 962 of opening 908 may be, for example, approximately, exactly,no greater than, or no less than, 0.05 inches, 0.06 inches, 0.07 inches,0.08 inches, 0.09 inches, 0.094 inches, 0.10 inches, 0.11 inches, 0.12inches, 0.13 inches, 0.14 inches, 0.15 inches, 0.16 inches, 0.17 inches,0.18 inches, 0.19 inches, 0.20 inches, 0.25 inches, 0.30 inches, 0.35inches, or 0.40 inches. As another example, the length 940 of opening951 may be, for example, approximately, exactly, no greater than, or noless than, 0.05 inches, 0.06 inches, 0.07 inches, 0.08 inches, 0.09inches, 0.094 inches, 0.10 inches, 0.11 inches, 0.12 inches, 0.13inches, 0.14 inches, 0.15 inches, 0.16 inches, 0.17 inches, 0.18 inches,0.19 inches, 0.20 inches, 0.25 inches, 0.30 inches, 0.35 inches, or 0.40inches. As another example, the length 960 may be, for example,approximately, exactly, no greater than, or no less than, 0.05 inches,0.06 inches, 0.07 inches, 0.08 inches, 0.09 inches, 0.094 inches, 0.10inches, 0.11 inches, 0.12 inches, 0.13 inches, 0.14 inches, 0.15 inches,0.16 inches, 0.17 inches, 0.18 inches, 0.19 inches, 0.20 inches, 0.25inches, 0.30 inches, 0.35 inches, or 0.40 inches. It can be desirablefor the length 940 to be equal to or less than length 960 in someembodiments.

In some embodiments, the lengths 962, 940, and 960 can be described as aratio versus the outer or inner tubular member's outer diameter ormaterial thickness. For example, the present embodiment comprises anouter diameter of the outer tubular member 904 of approximately 0.115inches. Accordingly, the lengths 962, 940, and 953 of the presentembodiment can be described as having a ratio of approximately 0.82,0.70, or 0.77, respectively, with respect to the outer diameter of theouter tubular member 904. Any of these three lengths may have a ratio inother embodiments with respect to the outer diameter of the outertubular member 904 of approximately, exactly, no greater than, or noless than, 0.5, 0.6, 0.7, 0.77, 0.8, 0.82, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4,1.5, 2.0, 2.5, 3.0, 3.5, or 4.0. Similar or identical ratios may applyto these lengths with respect to the outer diameter of the inner tubularmember. It should be noted that, however, if it is desirable for theopening 951 to not extend beyond the end face 964 of the outer tubularmember when cutting a polyp on the forward stroke, as the length 940increases, the length 960 must also increase, thus pushing the opening908 backward or proximally. In some embodiments, accordingly, it can bedesirable to have a shorter length 940, thus enabling the opening 908 tobe closer to the distal interface 964, such as for removing polyps thatare positioned toward the back of the uterus.

The tubing wall thickness of the outer tubular member 904 of the presentembodiment is approximately 0.01 inches. Accordingly, the lengths 962,940, and 953 of the present embodiment can be described as having aratio of approximately 9.4, 8.0, and 8.8, respectively, with respect tothe wall thickness of the outer tubular member 904. Any of these threelengths may have a ratio in other embodiments with respect to the wallthickness of the outer tubular member 904 of approximately, exactly, nogreater than, or no less than, 5, 6, 7, 8, 8.8, 9, 9.4, 10, 11, 12, 13,14, 15, 16, 17, 18, 19, or 20. Similar or identical ratios may apply tothese lengths with respect to the wall thickness of the inner tubularmember.

In this embodiment, the opening 908 in the outer tubular member 904 andthe opening 951 in the inner tubular member 914 are positioned andconfigured to cooperate to separate a polyp from the uterine wall oneither the forward stroke or rearward stroke of the inner tubular member914 with respect to the outer tubular member 904. FIGS. 9C through 9Fillustrate an example of using this embodiment to remove a polyp. InFIG. 9C, the opening 908 is positioned adjacent a polyp 922. In thisview, the opening 951 is presently positioned such that the opening 908is fully blocked off (e.g., its effective opening size is at its minimumor 0%), and the polyp 922 cannot yet be aspirated into or positionedthrough the opening 908.

With reference to FIG. 9D, the inner tubular member 914 has been pulledrearward or in the proximal direction with respect to the outer tubularmember 904. Accordingly, the opening 951 has been positioned adjacent tothe opening 908, and thus the polyp 922 is able to be positionedtherethrough. At this point, the polyp 922 may be separated from theuterine wall 926 by either continuing to translate the inner tubularmember 914 rearward, or by translating the inner tubular member 914 backforward or in the distal direction. FIG. 9E illustrates the innertubular member 914 having been pulled further in the proximal direction,thus causing cutting surfaces 952 and 953 to separate the polyp 922 fromthe uterine wall 926. FIG. 9F illustrates an example where the innertubular member 914 was returned in the distal direction or forwarddirection, thus causing surfaces 952 and 953 to separate the polyp 922from the uterine wall 926. In either case, the polyp 922 can then beaspirated through the inner lumen of the inner tubular member 914 forextraction and/or collection.

In this embodiment, cutting surfaces 952 of the inner tubular member aresubstantially blunt surfaces, and cutting surfaces 953 of the outertubular member comprise beveled or sharpened edges. In various otherembodiments, however, this relationship may be flipped, meaning thesurfaces 952 are beveled or sharpened and the surfaces 953 are blunt.Further, in some embodiments, all of the surfaces 952, 953 may bebeveled or sharpened, or all of the surfaces 952, 953 may be blunt orun-sharpened.

With reference to FIG. 9B, this embodiment illustrates a configurationwhere the inner tubular member 914 comprises a composite structure, witha distal tip portion 915 being coupled to a proximal portion 917. Oneadvantage of this design is that the outer diameter 932 of the distaltip portion 915 may be slightly larger than the outer diameter 934 ofthe proximal portion 917. This larger diameter 932 may form a closer fitwith the inner diameter of the outer tubular member 904, thuscontrolling the sliding friction between the inner and outer tubularmembers and/or controlling an amount of lateral movement and/or seepageor leakage of distention fluid that may pass between the inner and outertubular members. In practice, when manufacturing a tool such asdisclosed herein, it may be easier to control a relatively close fit ofjust of the distal tip portion 915 with the outer tubular portion 904than it would be to have the same relatively close fit along the entirelength of the inner tubular portion 914. In some embodiments, a seal,such as an O-ring, is included to help stop leakage of distention fluidbetween the inner and outer tubular members.

In this embodiment, the outer diameter 934 of the main elongate portionof the inner tubular member is approximately 0.089 inches. The outerdiameter 932 of the distal tip portion 915 is approximately 0.092inches. Further, the inner diameter of the outer tubular member 904 isapproximately 0.095 inches. Accordingly, in this embodiment, there isnominally 0.006 inches of total clearance between the main elongateportion of the inner tubular member 914 and the inner diameter of theouter tubular member 904. There is nominally half as much totalclearance, 0.003 inches, between the distal tip portion 915 and theinner diameter of the outer tubular member 904. Various other specificdimensions may be used in other embodiments; however, the generalprinciple of having a tighter clearance between the distal tip portion915 and the outer tubular member 904 than between the elongate portionof the inner tubular member 914 and the outer tubular member 904 can bedesirable in various embodiments. In some embodiments, having arelatively tight clearance between the distal tip portion and the outertubular member (such as, for example, approximately or no more than0.001, 0.002, 0.003, 0.004, or 0.005 inches) can help to smoothly guidethe inner tubular member with respect to the outer tubular member whenthe inner tubular member is translated in a longitudinal direction withrespect to the outer tubular member. In some embodiments, different, oradditional mechanisms are used to help guide the inner tubular memberwith respect to the outer tubular member, such as, for example, a lineartrack, one or more bearings, and/or the like.

FIGS. 10A-10G illustrate another example embodiment of a distal endconfiguration of a polypectomy device. The embodiment illustrated inFIGS. 10A-10G shares some similar features to other embodimentsdisclosed herein, and also include some differences. This embodimentcomprises an outer tubular member 1004, an inner tubular member 114, anda cutting block 1060. The inner tubular member 114 is similar in designto the inner tubular member 114 of the embodiment illustrated in FIGS.6A-6E, and all characteristics and dimensions discussed elsewhere withrespect to inner tubular member 114 can apply to this inner tubularmember 114. Further, the outer tubular member 1004, its opening 1008,and its blunt tip 112 are similar in design to the outer tubular member104 illustrated in FIGS. 6A-6E. However, instead of having two openings108 positioned opposite one another, the present embodiment comprises asingle opening 1008 that, in the current embodiment, desirably comprisesan angular width 1044, as shown in FIG. 10D, of greater than 180°.Angular width 1044 is measured to the radially outermost edges of theopening 1008, as shown in FIG. 10D. Further, the opening 1008 comprisesa depth 1042 that is greater than 50% of the outer diameter of the outertubular member, although various other depths may be used, such asdescribed above with reference to depth 842. This opening 1008 issimilar in design to the opening 808 as shown in FIGS. 8A-8F. However,instead of the opening extending completely through the distal tip ofthe outer tubular member, the opening 1008 ends before the blunt distaltip 112. There can be trade-offs in these two designs. For example,including a full blunt distal tip 112, as shown in FIG. 10A, can behelpful to make the tool less likely to cause trauma if the tool isunintentionally poked into the wrong tissue. An embodiment that has atleast a portion of the distal tip open, as illustrated in FIG. 8A, may,however, make it easier to reach polyps that are on the back or end wallof the uterus, such as the polyps 423 illustrated in FIG. 4.

With reference to FIG. 10B, the length 1040 of the opening 1008 cancomprise any of the same dimensions described above, for example, withreference to length 634 shown in FIG. 6B. The angular opening width 1044of the opening 1008, as shown in FIG. 10D, can comprise any of thedimensions described herein, for example, with respect to angle 844illustrated in FIG. 8F. Further, the thickness of the outer and innertubular members, in this embodiment and any other embodiments disclosedherein may be of any thickness as described elsewhere herein.

Another difference in the embodiment of FIGS. 10A-10G as compared to theembodiment of FIGS. 6A-6E is that this distal and configurationcomprises a cutting block 1060 positioned at a distal end of the opening1008. The cutting block 1060 is generally cylindrical in shape and sizedwith an outer diameter 1064 that fits within the inner diameter of theinner tubular member 114. A proximal surface of the cutting block 1060comprises an inclined shape shown by angle 1062, which forms a cuttingsurface 653 which can be used to help cut the polyp 1022 to remove thepolyp from the uterine wall 1026. The inclined proximal surface can helpto act like a guillotine or other angled blade, which can make it easierto cut the body tissue by gradually cutting the tissue as the innertubular member 114 is advanced, instead of trying to cut through theentire polyp at the same time. The cutting block 1060 further comprisesa longitudinal length 1066, defined in FIG. 10E as the distance from thedistal end of the opening 1008 of the outer tubular member 1004, to theclosest point of the angled proximal surface of the cutting block 1060.In this embodiment, angle 1062 is approximately 30°. In otherembodiments, the angle 1062 can be greater or less, such as, forexample, approximately, exactly, no greater than, or no less than, 10°,20°, 30°, 40°, 45°, 50°, or 60°.

FIGS. 10E-10G illustrate an example of using this embodiment to remove apolyp 1022. In FIG. 10E, the polyp 1022 has been positioned through theopening 1008. In FIG. 10F, the inner tubular member 114 has beenadvanced forward and is approaching the cutting block 1060. In FIG. 10G,the inner tubular member 114 has been advanced forward far enough thatthere is no gap left between the end opening of the inner tubular member114 and the cutting block 1060, and the polyp 1022 has been separatedfrom the uterine wall 1026. With continued vacuum suction, the polyp1022 can be aspirated through the inner lumen of the inner tubularmember 114. In some embodiments, the cutting block comprises an angle1062 of zero degrees, and the front cutting edge 652 of the innertubular member 114 is instead angled (using any of the angles describedabove with reference to angle 1062).

FIGS. 11A-11G illustrate another embodiment of a distal endconfiguration for a polypectomy device. The embodiment illustrated inFIGS. 11A-11G is the same as the embodiment described above with respectto FIGS. 10A-10G, with the exception of different designs for the innertubular member 1114 and cutting block 1160. The opening 1108 is similarto opening 1008 and can have similar dimensions. The cutting block 1160is similar to the cutting block 1060, and can comprise the same range ofproximal surface angles 1062 as the cutting block 1060 of FIG. 10E. Thelongitudinal length 1066 of the cutting block 1160, however, isdesirably longer than the length of the cutting block 1060, because theinner tubular member 1114 comprises an angled surface configured toengage the cutting block 1160, instead of a straight distal surface, asillustrated in FIG. 10E.

The inner tubular member 1114, instead of having a flat cylindricallyshaped or annularly shaped distal surface 652, as shown in FIG. 10E,comprises an angled ring portion 1170 extending from the distal end ofthe inner tubular member 1114 and having distal cutting surface 652.This ring member 1170 is sized and shaped to fit around the outside ofthe cutting block 1160, enabling cutting surface 652 to cooperate withcutting surface 653 to cut a polyp. The ring member 1170 and the cuttingblock 1160 work together to slice polyp material from the uterine wall.The ring member 1170 is angled back or comprises a distal facepositioned at angle 1164 as measured from a vertical plane asillustrated in FIG. 11E. Further, a distal surface 1167 of the innertubular member 1114, positioned behind the distal surface of the ringmember 1170, is angled back at an angle 1168 with reference to thevertical plane. The distal surface 1167 and/or the surface 652 can actas cutting surface, depending on where a polyp is positioned during thecutting process.

In this embodiment, angle 1062 can have similar dimensions as discussedabove with reference to FIG. 10E. Angle 1164 is approximately 60° in thepresent embodiment. In other embodiments, however, angle 1164 may be adifferent dimension, such as, for example, approximately, exactly, nogreater than, or no less than, 10°, 20°, 30°, 40°, 50°, 60°, 70°, or80°. In this embodiment, angle 1168 is approximately 25.6°. Further, adistal tip surface of the ring member 1170 may comprise an angle similarto or the same as angle 1062, as can be seen in FIG. 11E where thatsurface is shown coincident with angle 1062. Each of these angles may bedifferent in other embodiments, such as, for example, approximately,exactly, no greater than, or no less than, 10°, 20°, 30°, 40°, 50°, 60°,70°, or 80°.

FIGS. 12A-12F illustrate another embodiment of a distal endconfiguration of a polypectomy device. This embodiment comprises anouter tubular member 1204 but does not comprise an inner tubular memberas shown in many of the other embodiments disclosed herein. With many ofthe other embodiments disclosed herein, the inner tubular member is whatcomprises an inner lumen through which a separated polyp will pass forcollection or disposal. In this embodiment, however, the outer tubularmember 1204 comprises the inner lumen for extraction or collection ofseparated polyps.

The outer tubular member 1204 has a cutter mechanism 1270 attached tothe distal end of the outer tubular member 1204. The cutting mechanism1270 comprises an opening 1208 that provides a passageway into thecentral lumen of the outer tubular member 1204. The cutting mechanism1270 further comprises a flexible cutter 1280 positioned therein, theflexible cutter 1280 being coupled to an actuation member (e.g.,actuation member, rod, link, linkage, pushrod, and/or the like), in thiscase an actuation rod 1214. The actuation rod 1214 can be connected to,for example, the trigger or actuation mechanism of the handle in a waysimilar to the inner tubular members of other embodiments (e.g.,movement of the trigger or actuation mechanism of the handle causestranslation of the actuation rod 1214). In the retracted state shown inFIG. 12B, the flexible cutter 1280 is retracted within the cuttingmechanism 1270. After a polyp has been aspirated or otherwise positionedinto the cutting mechanism 1270 through the opening 1208 in the distalend of the cutting mechanism 1270, the actuation rod 1214 can betranslated forward, causing the flexible cutter 1280 to move forward anddownward through the cutter channel 1284, thus separating the polyp fromthe uterine wall.

In some embodiments, the flexible cutter 1280 may be formed from, forexample, a polymer or other material that enables the flexible cutter1280 to flex and bend downward to be pushed through the cutter channel1284. In some embodiments, with reference to FIG. 12D, the flexiblecutter 1280 may comprise a thinner portion 1282 that may help to enablethe flexible cutter 1280 to flex.

FIGS. 13A-13C illustrate another embodiment of a distal endconfiguration of a polypectomy device. One difference in this embodimentfrom some of the other embodiments disclosed herein is that the opening1308 for passing therethrough of a polyp for removal from the uterinewall is positioned on the distal tip of the instrument instead of on aside wall of the distal end of the instrument. This is similar, at leastwith respect to positioning of the opening 1308, to the positioning ofthe opening 1208 illustrated in FIG. 12F.

In the embodiment illustrated in FIGS. 13A-13C, the instrument comprisesan outer tubular member 1304 shown in FIG. 13A, and an inner tubularmember 1314, shown in FIG. 13B (with the outer tubular member 1304hidden). FIG. 13C illustrates an end view of the polypectomy device,with the inner tubular member 1314 being shown partially in hidden linesbecause part of the inner tubular member 1314 is blocked from view bythe distal end face 1370 of the outer tubular member 1304. As can beseen in FIG. 13C, the cutout or opening 1351 in the distal end surfaceof inner tubular member 1314 can be rotated with respect to the outertubular member 1304, thus causing the effective opening size of opening1308 into the inner lumen of the inner tubular member 1314 to vary. Inthis embodiment, the openings in the outer and inner tubular memberseach comprise an angular width of 1344 and 1345, respectively, that areapproximately 180°. Accordingly, in this embodiment, the cutout oropening 1351 of the inner tubular member 1314 can be selectivelycompletely exposed through opening 1308, completely hidden by end face1370 of the outer tubular member 1304, or anything in between. In otherembodiments, the angular widths 1344 and 1345 may vary. For example, ifangle 1344 of the outer tubular member 1304 is greater than 180°, andangle 1345 of the inner tubular member 1314 remains as 180°, the opening1351 into the inner lumen of the inner tubular member 1314 will never befully covered by the end surface 1370. This may be desirable in someembodiments, such as to provide at least a small controlled amount ofleakage of distention fluid into the inner lumen of the inner tubularmember 1314. This may be desirable to enable or facilitate moreefficient suction of a removed polyp through the inner tubular member1314 and into a collection chamber.

In some embodiments, a polypectomy device may comprise both a distal endopening, such as is shown in FIG. 13A, and a side opening, such as isshown in FIG. 7A. One advantage of having both end openings and sideopenings is that an end opening may be more desirable for use withpolyps positioned at the back uterine wall, such as polyps 423 shown inFIG. 4, and a side opening may be more desirable for polyps positionedat the side wall of the uterus, such as polyps 422 shown in FIG. 4.Further, an opening positioned along the side of the tubes may be ableto have a larger effective opening size than an opening positioned atthe distal end, since the opening at the distal end is limited by thediameter of the tubes. In some embodiments, the benefits of both sideopening and end opening designs are combined into a single opening, suchas is shown in FIG. 8A. With the embodiment shown in FIG. 8A, theopening 808 extends from the side of the outer tube 804 all the waythrough the distal end of the instrument.

FIGS. 14A-14F illustrate another embodiment of a distal endconfiguration of a polypectomy device. This embodiment is similar to theembodiment illustrated in FIGS. 8A-8F, as described above, with theexception of the distal tip configuration. The present embodimentcomprises a flat distal tip as opposed to the rounded distal tip of FIG.8A. Further, the embodiment of FIG. 14 A comprises a protrusion 1475which may, for example, be configured to act as a pivot point for theinner tubular member 1414 as it rotates. Although not shown in thesefigures, the inner tubular member 1414 may comprise a pin or otherprotrusion that fits into a hole or depression of the protrusion 1475,thus enabling the protrusion 1475 to act as a pivot point. In someembodiments, the protrusion 1475 may help to limit translation of theinner tubular member 1414 distally beyond the outer tubular member 1404,similar to as described above with reference to the raised lip 2452 ofFIGS. 24A-24C.

The dimensions 840 and 844 of outer tubular member 1404 may be similaror identical to the dimensions 840 and 844 of the embodiment of FIGS.8A-8F, and these dimensions may take any of the numbers given above.Further, the dimensions 740 and 744 of the inner tubular member 1414 maybe similar or identical to any of the numbers given above for dimensions740 and 744 of inner tubular member 214 illustrated in FIGS. 8C and 8F.As shown in FIG. 14F, in this embodiment, angular width 844 isapproximately 180 degrees, but angular width 744 is less than 180degrees, thus leading to the inner tubular member's cutting surfacesbeing desirably recessed somewhat with respect to the outer tubularmember, when the inner and outer tubular members are rotationallyaligned as shown in FIG. 14F.

Blade or Cutter Configurations

As mentioned above, various embodiments of polypectomy devices disclosedherein may comprise sharpened or un-sharpened blades or cutting surfacesconfigured to separate a polyp from the uterine wall. Because polyps arerelatively soft or gelatinous, particularly as compared to other objectsin need of removal, such as fibroids, a less sharp or blunter surfacemay be acceptable in a polypectomy device to cut or remove the polyp.Further, a blunter or less sharp surface may even be desirable, becauseit can be safer by having less risk of causing trauma if that surfacewere to contact a portion of body tissue that is not intended to be cut.

FIG. 6E, as discussed above, illustrated one example of a cuttingsurface 652 having a chamfered surface next to it, but not coming to apoint like a typical blade would. These concepts can be applied to anyof the embodiments disclosed herein. FIGS. 15A-15C illustrate asimplified example of cutting faces, edges, or surfaces 1552, 1552′, and1552″ that may be used with any of the embodiments disclosed herein(e.g., with cutting surfaces 652, 653, 752, 753, 852, 952, 953, 1167, orsimilar surfaces shown in various figures).

FIG. 15A illustrates a cross-sectional view of an inner or outer tubularmember having material thickness 1515 and having a sharpened cuttingedge 1552 formed by a chamfer being created that is of thickness 1517,equal to the full thickness 1515 of the material. This provides anexample of a sharpened cutter or blade. FIG. 15B illustrates a versionof an inner or outer tubular member 1514′ having an un-sharpened cuttingface or surface 1552′. In this embodiment, the material thickness is1515 and the cutting face 1552′ has a thickness equal to the materialthickness 1515.

In practice, it can be difficult to form an edge or surface that doesnot have some sort of chamfer or imperfection at its edges. Further, ifa surface like the surface 1552′ were used, with no chamfer or roundingat all at the corners, the side edges of the surface 1552′ may still berelatively sharp. Accordingly, it may be desirable in some embodimentsto have a cutting face that is not sharpened (for example, using amanufacturing process that makes the cutting edge come to a point) butthat may still have some sort of chamfer, round, or imperfection at itsedge. FIG. 15C illustrate such an example, wherein inner or outertubular member 1514″ comprises a cutting face or surface 1552″ and achamfer 1554 at its edge. In this example, the width 1517″ of thechamfer 1554 is less than the width 1515 of the material of the tubularmember 1514″. The example shown in FIG. 15C is similar to the exampleshown in FIG. 6E, but may be used with any other embodiments, also. Thechamfer, round, or imperfection 1554 may be formed in various ways. Forexample, it may be formed using a secondary operation, such as acutting, grinding, or deburring operation. It may also be formed intothe material during injection molding or the like. In some embodiments,the chamfer, round, or imperfection 1554 may be a result of whatevermanufacturing process is used to create the cutting surface 1552″ andmay not require a secondary operation. In some embodiments, both sidesof the surface 1552″ comprise a chamfer, round, or imperfection, but atleast a portion of the surface 1552″ remains flat or blunt (e.g., notsharpened to a point).

As discussed above, tubing used to create portions of the polypectomydevices disclosed herein, including the example blade or cuttingsurfaces shown in FIGS. 15A-15C, may comprise a variety of thicknesses.For example, tubing thickness, and thus thickness 1515 shown in FIGS.15A-15C, may be in some embodiments somewhere within the range of 0.015inches to 0.002 inches, or approximately, exactly, no greater than, orno less than, 0.015 inches, 0.014 inches, 0.013 inches, 0.012 inches,0.011 inches, 0.010 inches, 0.009 inches, 0.008 inches, 0.007 inches,0.006 inches, 0.005 inches, 0.004 inches, 0.003 inches, or 0.002 inches,corresponding to 6 through 18 gauge hypodermic tubing sizes. Thechamfer, round, or imperfection 1517″ may in various embodiments bevarious percentages of the overall width 1515. For example, in someembodiments, the width 1517″ may be approximately, exactly, no lessthan, or no greater than, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60%,70%, or 75% of the total material thickness 1515.

Polypectomy Device Handles

Various human interface features may be used with polypectomy devicesdisclosed herein. For example, various embodiments disclosed hereincomprise a handle portion sized and configured to be held and/ormanipulated by a human hand during use. The handle portion may comprisefeatures that enable the user to grip the handle and reposition thepolypectomy device, such as by rotating the device about a longitudinalaxis of the outer tubular member and/or inserting or retracting theouter tubular member into or out of the patient's uterus (e.g., throughthe working channel of a scope or other instrument). The handle portionmay further comprise one or more actuating members, such as a trigger,button, lever, and/or the like that enables the user to cause relativemotion of the inner tubular member with respect to the outer tubularmember, and/or relative motion of another actuating member with respectto the outer tubular member, such as the actuation rod 1214 of FIG. 12C.

FIGS. 16A and 16B illustrate additional details of the handle 102 of thepolypectomy device 100 of FIG. 1A. The handle 102 comprises a main body1601 having an actuating member 112 slidably coupled therewith. Theactuating member 112 can translate back and forth to cause back andforth translating motion of the inner tubular member 114 with respect tothe outer tubular member 104. The handle 102 further comprises a spring1602 positioned to bias the actuating member 112 in one direction. Inthis embodiment, the actuating member 112 is biased by the spring 1602in the forward or distal direction. However, in other embodiments, theactuating member 112 may be biased in the proximal direction (or evenbiased to a central position between the proximal and distal extents).The actuating member 112 further comprises a finger surface 1604 shapedto engage a human finger. The surface 1604 may, for example, be shapedto engage the index finger or thumb or other finger of a user's hand.

In this embodiment, the outer tubular member 104 is affixed to the mainbody 1601 of the handle 102, and the inner tubular member 114 is coupledto and moves along with the actuating member 112. In this embodiment,the inner tubular member 114 extends into the vacuum port 116, and thusenables polyps or portions of polyps that have been removed from theuterine wall and aspirated through the inner tubular member 114 to beexpelled at the vacuum port 116, desirably into a collection systemfluidly coupled with the vacuum port 116.

FIGS. 17A and 17B illustrate additional details of the handle portion202 of the embodiment illustrated in FIGS. 2A and 2B. In thisembodiment, the handle portion 202 comprises a main body 1701 affixed tothe outer tubular member 204. The handle 202 further comprises anactuating member 212 coupled to the inner tubular member 214 such thatthe rotation of the actuating member 212 with respect to the main body1701 causes relative rotation of the inner tubular member 214 withrespect to outer tubular member 204. A spring 1702 provides acompression or tension force that keeps the actuating member 212 andmain body 1701 from freely rotating with respect to one another.Accordingly, depending on the strength of the spring 1702, a particularpredetermined torque force on the actuating member 212 will have to beapplied to begin rotation of the rotating member 212 with respect to themain body 1701.

It should be noted that the handle designs of FIGS. 16A-16B and 17A-17Bare relatively minimalistic designs that can be used to create afunctioning device at relatively low cost. It may be desirable, however,in some embodiments to have an at least somewhat more complicated handledesign that may be easier and/or more comfortable to use. For example,the embodiment illustrated in FIGS. 18A and 18B illustrates an exampleof a handle 1802 that is more ergonomically shaped. The handle 1802comprises a housing 1801 having two halves (for example, twoinjection-molded polymer halves that can be joined during assembly). Thehandle 1802 further comprises a trigger or actuating member 1812 that isbiased in an extended position by spring 1820, when spring 1820 isconnected to protruding member 1821 of the actuating member 1812(although FIG. 18B shows spring 1820 disconnected from protruding member1821). A user, when using the handle 1802, can repeatedly compress thetrigger or actuating member 1812, i.e. pull it toward the protrudingmember 1803, to cause rotation of the inner tubular member 114 withrespect to outer tubular member 104 (not shown). In various embodiments,the protruding member 1803 is shaped to be gripped by a human hand andprotrudes radially in a direction oriented at a specific angle withrespect to an opening (e.g., opening 808 of FIG. 8A, or any other distalend opening disclosed herein). For example, the protruding member 1803may be oriented at 90 degrees with respect to the opening (similar to asshown in FIG. 1A, where the actuating member 112 is oriented atapproximately 90 degrees from the openings 108). In various embodiments,this orientation can be various angles. In some embodiments, the angleis desirably configured such that the protruding member 1803 is pointingin a downward direction when removing polyps in the most commonlocations. For example, in some embodiments, the orientation is in therange of 90-180 degrees. In this embodiment, the handle 1802 furthercomprises a geartrain 1804 or plurality of gears 1804 that convert thepivoting motion of the trigger or actuating member 1812 into rotationabout a different axis of the inner tubular member 114. Otherembodiments may use different geartrain configurations, and otherembodiments may use a configuration that converts the rotating motion ofthe trigger 1812 into translating motion of the inner tubular memberinstead of rotational motion.

The polypectomy devices disclosed herein are not limited to being usedwith handles of the specific designs shown in the figures of the presentapplication. One of skill in the art will recognize that various otherhandle and triggering mechanisms may be used to cause relative motion ofone member with respect to another member within the uterus.

Additional Embodiments

In some embodiments, the devices and methods disclosed herein allow forremoval of tissue using a rotating motion combined with a blade orcutting edge or surface (sharpened or unsharpened). In some embodiments,the devices and methods disclosed herein allow for removal of tissueusing a mechanical biting motion by a set of cutting jaws. In someembodiments, the devices and methods disclosed herein allow for removalof tissue through a stationary jaw and a movable wire. The use ofmechanical motion to remove tissue may further allow for the use of asaline solution to distend the uterus, which may reduce the risk ofelectrolyte imbalance and prevent thermal injury.

Following are descriptions of various additional polypectomy deviceembodiments, any of which may comprise features that can be combinedwith any of the other polypectomy devices disclosed herein. For example,the handle and drive mechanism configurations discussed below may becombined with any of the distal end configurations described above orbelow.

FIGS. 19A-191 illustrate another embodiment of a polypectomy device1900. FIG. 19A illustrates a side view of the polypectomy device 1900.The device may have a shaft 1901, handle 1902, trigger 1612, a port1916, and/or a vacuum source 1932. The vacuum source 1932 may be influid connection with the handle 1902 or shaft 1901 via the port 1916.

The device 1900 may be a handheld device that mechanically rotates atube with “blades.” The blades may have been formed by bending some cutout sections of a thin walled tube (as shown in FIGS. 19E-19G). Thedevice may be connected to a vacuum source that is used to pull thespecimen (such as a polyp) into the distal tip of the device shaft. Thevacuum pressure may, in some embodiments, be applied to the shaft onlywhen the trigger has been pressed. The control of the vacuum may beimportant in maintaining the distention of the uterus. In someembodiments, however, the vacuum may be controlled by another element,such as a foot pedal.

The shaft 1901 may comprise a pair of concentrically aligned tubes(e.g., outer and inner tubular members, similar to as described abovewith respect to other embodiments). The inner tube may be modified tocreate a cutting edge to sever the polyp once it has been suctioned intothe inner tube (e.g., as shown in FIGS. 19E-19G).

The polypectomy device 1900 would be introduced into the uterus using ascope similar to the scope of FIG. 3 to provide visualization and aninflow port for saline solution needed to distend the uterus.

The trigger 1912 may have multiple positions. The trigger may have threepositions. In the first position, suction in the device may be turnedoff. In the second position, suction in the device may be turned on. Inthe third position, the blades of the device may be activated. This maybe desirable to, among other things, only activate suction just beforecutting the polyp, to minimize loss of distention fluid. In someembodiments, however, the suction may be controlled by a foot pedal orother device, instead of being controlled by a multi-stage trigger 1912.

FIG. 19D illustrates the shaft 1901 of the improved polypectomy device1900 in more detail, according to one embodiment. The shaft 1901 mayhave an outer tube 1904, an inner tube 1914 with cutting edges 1915, adrive gear 1917, and a bearing 1919. The shaft may be connected to avacuum source 1932.

There may be a gear 1917 that is welded (or otherwise coupled) to theinner tube 1914 and enables the inner tube 1914 to be rotated by a setof gears in the handle (for example, similar to the gear train 1804 ofFIG. 18B). The rotation of the inner tube 1914 may allow for the cuttingedges 1915 to cut tissue. In some embodiments, polyps may be transectedusing suction or vacuum alone. The cutting efficiency of the blades maynot be very high. This may be intentional, such as by not sharpening theblades, which can increase safety and reduce manufacturing costs. Thetorque and rotational speed of the shaft rotation may not be very high,because, for example, the inner tube 1914 may be rotated by a human handmanipulating the trigger 1912, as opposed to a motor spinning the tube1914.

In this and various other embodiments disclosed herein, the speed ofreciprocation (e.g., cutter translating and/or rotating back and forth)can be, for example, approximately, exactly, no greater than, or no lessthan, 0.5, 1, 2, 3, 4, or 5 cycles per second. It may be desirable insome embodiments to have a relatively low speed (e.g., cycles persecond), to enable manual positioning of the opening for each cut.

FIGS. 19E-19G illustrate an example process for forming the cuttingedges 1915 of the improved polypectomy device in more detail, accordingto one embodiment. The cutting edges 1915 may be formed in the innertube 1914 of the device.

The cutting edges 1915 may be formed, for example, by cutting andtrimming the tip of a hypotube to enable points to be formed. The pointsmay comprise teeth, which may be created by removing adjacent material(e.g., as shown in FIG. 19E). Once the points are formed (e.g., as shownin FIG. 19F), they may be bent or folded back inside the tip of the tubeto form one or more reverse facing cutting edges (e.g., as shown in FIG.19G).

FIGS. 19H and 191 illustrate how the cutting edges 1915 of the improvedpolypectomy device 1900 may remove tissue, according to one embodiment.A vacuum may pull the polyp or tissue specimen 1922 into the tube 1914,through the end of the tube with cutting edges 1915. While the vacuumcontinues to be applied, spinning the tube 1914 allows the cutting edges1915 to shear the polyp or specimen 1922, disconnecting it from theuterine wall or other body tissue 1926. Afterwards, the vacuum mayfurther prevent the specimen from falling out of the tube.

FIG. 19B illustrates how tissue capture may be performed by the improvedpolypectomy device 1900, according to one embodiment. In the embodimentshown in FIG. 19B, the device may be able to capture the tissue that iscut off and removed. The device may have a tissue capture chamber 1920in the handle 1902 that would enable the physician to send the specimen1922 to the pathology lab with no need for an auxiliary tissue trap. Thecapture chamber 1920 may eliminate the risk of biohazardous materialhandling.

The trigger 1912 may have a member 1950 attached that translates througha slot in the handle to provide a means for controlling the vacuum. Forexample, gate 1950 may selectively block off or open up tube 1951, toselectively enable vacuum to be applied to tube 1951, and thus thetissue capture chamber 1920. It may be important to limit the vacuumduration as the pressure will empty the uterus of its distention fluidand force the use of larger volumes of the fluid. It may be ideal if thetotal volume of distention fluid can be <1 liter to minimize safetyconcerns and efforts to exchange multiple fluid bags.

The tissue capture chamber 1920 may be in fluid communication with thecutting tube 1914. The tissue capture chamber 1920 may be removable,such that the device may operate without the tissue capture chamber1920. The tissue capture chamber 1920 may have a screen 1952 disposedwithin it. The tissue capture chamber 1920 may contain a fluid forholding any collected specimens. The tissue capture chamber 1920 may bein fluid connection to a vacuum source, such as by means of a hose,tube, or vacuum line 1951.

The vacuum line may pass through a gate 1950. The gate 1950 may have anopen configuration and a closed configuration. When the gate 1950 isclosed, the flow path of the vacuum line 1951 may be closed. When thegate 1950 is open, the flow path of the vacuum line 1951 may be open.When the trigger 1912 of the device is pressed, the gate 1950 may slideacross the vacuum line 1951 into its open configuration and the flowpath of the vacuum line may be opened.

FIG. 19C illustrates how cutting tube 1914 rotation may be performed bythe improved polypectomy device 1900, according to one embodiment. Inthe embodiment of FIG. 19C, there is a drive mechanism 1980 that linksthe translation of the trigger 1912 to the rotation of the cutting tube1914. The inner tube 1914 may be connected to a drive gear 1917, and thedrive gear 1917 may be in mechanical communication with a second spurgear 1919. The second spur gear 1919 may be in mechanical communicationwith a set of bevel gears 1921. The set of bevel gears 1921 may be inmechanical communication with a first spur gear 1923. The trigger mayhave a rack 1925 that would drive a pinion gear (or first spur gear)1923 and a set of bevel gears 1921 to translate the motion and energy.

As the trigger 1912 is pressed, the rack 1925 may engage the first spurgear 1923, creating a rotation of the set of bevel gears 1921 and thesecond spur gear 1919. The rotation of the second spur gear 1919 wouldrotate the drive gear 1917, causing the rotation of the cutting tube1914. In some embodiments, the trigger 1912 comprises a dead zone 1927that, for example, enables the vacuum suction to start (e.g., viamovement of gate 1950 of FIG. 19B) prior to starting rotation of theinner tube 1914.

FIGS. 20A-20C illustrate another embodiment of an improved polypectomydevice 2000. The device 2000 shown may be a handheld device thatmechanically opens and closes jaws 2090 to take bites of the polyp,rather than cutting the polyp through the rotation and/or translation ofa cutting edge. There may be a shaft 2001 with cutting jaws 2090, ahandle 2002, a trigger 2012, a removable tissue chamber 2020, a vacuumgate 2050, and/or a vacuum line 2051 connecting a vacuum source 2032.The removable tissue chamber 2020 and vacuum gate 2050 may be within thehandle 2002, along with portions of the vacuum line 2051, and may besimilar to, for example, tissue chamber 1920 and vacuum gate 1950 ofFIG. 19B. There may be a port that connects portions of the vacuum lineto the handle. The handle may include a vacuum control gate conceptsimilar to the one shown in FIG. 19B.

The cutting jaws 2090 may have an open tissue path at their proximalattachment point where vacuum is applied to remove the specimen from thejaws. A “cutting edge” 2091 may formed at the tip of one jaw (or bothjaws) by utilizing a thin wall at the jaw tip. The cutting jaws 2090 mayhave an open configuration (e.g., FIG. 20C) and a closed configuration(e.g., FIG. 20B). In the open configuration, the cutting jaws 2090 maybe positioned around a polyp or tissue specimen. In the closedconfiguration, the cutting jaws 2090 may move towards each other so thatthe cutting edge 2091 may cut off the polyp.

The trigger 2012 may have multiple positions. The trigger 2012 may havetwo positions. In the first position, the jaws 2090 may be in the openconfiguration and the vacuum turned off. In the second position, thejaws 2090 may move to their closed configuration and the vacuum turnedon. The trigger 2012 may comprise a dead zone, such that the vacuum isnot enabled at the same time as when the jaws 2090 begin moving.

FIG. 21 illustrates how the cutting jaws 2090 may be opened and closed,according to one embodiment. The jaws 2090 may be closed by use of atranslating tube 2014 that slidably engages a cam surface 2015 on thejaw to force it to close. The trigger may be used to slide thetranslating tube 2014. A spring or elastic member 2017 may be used toreturn the jaws 2090 to an open position once cutting is completed. Acoil spring 2017 may also keep the jaws 2090 open until the translatingtube 2014 cams them closed.

FIGS. 22A-22C illustrate how a distal end 2206 of an improvedpolypectomy device may use a polyp slicer, according to one embodiment.The device may be a handheld device that mechanically opens and closesto take bites of the polyp. The cutting mechanism may involve astationary lower jaw 2209, such as by forming the outer tube 2204, and amovable wire 2211. Thus, the cutting jaws 2090 shown in FIGS. 20A-20Care not used, although the handle and shafts may be identical orsimilar.

The lower cutting jaw has been replaced by a fixed plane 2209 made bysculpting the outer tube 2204. The upper jaw has been replaced by a thinwire 2211 strong enough to cut the tissue, but thin enough to slice thetissue. The wire 2211 would desirably be set to bypass the lower jaw2209 to create a shearing action similar to the blades of a scissor. Theformed wire upper jaw 2211 may be closed by use of a translating tube2214 that slidably engages a surface 2215 on the jaw to force it toclose. A spring (similar to spring 2017 of FIG. 21) may be used toreturn the jaw 2211 to an open position once cutting is completed.

Additional/Alternative Features

Following are various options/features that may be included in any ofthe various embodiments of polypectomy devices disclosed herein. In someembodiments, the cutting tube may be a thin-walled tube. In someembodiments, the distal end of the cutting tube may not bebulbous-shaped. In some embodiments, the device may be configured toapproach polyp tissue straight on (e.g., with an opening in a distalend). In some embodiments, the distal end of the cutting tube may beopen for receiving polyp tissue. In some embodiments, a side window mayor may not be present in the cutting tube. In some embodiments, theinner tube and the outer tube in the shaft may be concentrically alignedtubes, both of which have open distal ends. In some embodiments, theblades or cutting edges (which may or may not be sharpened) are bentinwards (towards the proximal end of the cutting tube) back into thedevice, such that any engaged tissue cannot escape or fall out of thedevice once the tissue is pulled into the tube.

In some embodiments, the vacuum function of the device may be used aloneto sever and capture polyps. The vacuum may not need to be paired withanother cutting mechanism. In some embodiments, the device may not needa mechanical action to sever and retrieve polyp tissue, with someexamples of mechanical action including using a lasso or wire loop, orrotating a tube with blades in it. In some embodiments, the device maykeep the uterus distended or maximize uterus distention in the course ofremoving polyps. In some embodiments, the device may help conservedistention fluid over the course of a polypectomy. In some embodiments,the device may have a dual trigger design for engaging a mechanism usedto mechanically cut the polyp and for varying the suction power of thevacuum source. In some embodiments, the device has a single trigger thatmay control both the functions of cutting (such as the rotation of atube), and the suction (such as varying the power of the vacuum source).In some embodiments, the device has a single trigger that may be amulti-function trigger.

In some embodiments, the device may have a thin-walled cutting tube witha non-bulbous tip, and the tip may be open at the distal end forreceiving tissue. The cutting tube may not have any openings in the sidewall. In some embodiments, the device may have cutting jaws that cansimultaneously cut, envelope, and retrieve polyp tissue. The retrievingof the polyp tissue may be aided by suction. In some embodiments, thedevice may use gear mechanisms to rotate the device's shaft or cuttingelement.

Polypectomy Methods

Various methods described herein may be used to remove polyps orportions of polyps using polypectomy devices disclosed herein. FIG. 23illustrates one example embodiment of such a process; however, theprocess flow illustrated in FIG. 23 is not the only process that can beused to remove polyps with the devices disclosed herein.

The process flow begins at block 2302. At block 2304, a doctor inserts ascope into the uterus, such as the scope 300 shown in FIGS. 3 and 4. Atblock 2306, the doctor distends the patient's uterus. For example, thedoctor may cause distention fluid to pass through the scope and into theuterus. At block 2308, the doctor inserts an elongate tubular member ofa polypectomy device through a working channel of the scope. Forexample, outer tubular member 104 illustrated in FIG. 4 may be insertedthrough the working channel of the scope of 300. At block 2310, uponfurther insertion of the elongate tubular member into the workingchannel of the scope, the doctor causes the distal end of thepolypectomy device to extend into the uterus beyond the distal end ofthe scope working channel. An example of this can be seen in FIG. 4,where the distal end 106 is protruding into the uterus 420.

At block 2312, the doctor positions an opening in the distal end of thepolypectomy device adjacent a polyp. For example, the doctor maymanipulate the handle of the polypectomy device to cause an opening inthe distal end to be positioned adjacent a polyp for removal. At block2314, the doctor causes at least a portion of the polyp to be positionedthrough the opening. This may be accomplished via manipulation of thedistal end of the polypectomy device and/or activating a vacuum suctionthat causes a portion of the polyp to be aspirated through the hole.

At block 2316, the doctor operates an actuation member, such as atrigger, button, and/or the like, causing a cutting surface to separatethe polyp or a portion of the polyp from the uterine wall. For example,the doctor may manipulate a trigger that causes an inner tubular memberto translate and/or rotate with respect to an outer tubular member, andcauses a cutting surface or cutting surfaces to separate the polyp orportion of the polyp from the uterine wall.

At block 2318, the separated polyp or portion of the polyp is cause tobe transferred through the elongate tubular member using vacuum suction.For example, the doctor may manually activate the vacuum suction, suchas by using a foot pedal or other activating member, and/or the vacuumsuction may be automatically activated using a multistage trigger,and/or the like. This vacuum may cause the removed polyp or portion ofthe polyp to be aspirated through the inner or outer tubular members andaspirated into a collection system.

At block 2320, the process flow varies depending on whether additionaltissue needs to be removed, such as additional polyps or an additionalportion of the same polyp. If additional tissue needs to be removed, theprocess flow proceeds back to block 2312 and proceeds as describedabove. If no additional tissue needs to be removed, the process flowproceeds to block 2322. At block 2322, distention fluid is removed, suchas through the scope, and the polypectomy device and scope are removedfrom the uterus. The process flow ends at block 2324.

Additional Embodiments of Polypectomy Devices

FIGS. 25A-25U illustrate another example embodiment of a polypectomydevice 2500. FIGS. 25A and 25B illustrate side and cross-sectionalviews, respectively, of the entire assembly. FIGS. 25C and 25Dillustrate detail cross-sectional views. FIGS. 25E-25G illustratevarious views of an actuating member or trigger of the assembly. FIGS.25H and 251 illustrate an outer tubular member assembly 2504. FIGS. 25Jthrough 25L illustrate a cutting block 2560, and FIGS. 25M and 25Nillustrate an outer tubular member 2505, which can be coupled to thecutting block 2560 to form the outer tubular member assembly 2504. FIG.25O illustrates an inner tubular member assembly 2590 that comprises aninner tubular member 2514, a tubular cutter 2515, and a guide member2517. FIGS. 25P through 25R illustrate additional details of the tubularcutter 2515. With reference to FIG. 25O, the tubular cutter 2515 may beattached to the inner tubular member 2514 at junction 2588. In thisfigure, and also some of the other figures, such as FIGS. 25S and 25T, achamfer at the distal end of the inner tubular member 2514 (e.g., atjunction 2588) is illustrated, although such a chamfer may not bevisible in the finished product. Such a chamfer may, for example, helpwith the joining process, such as laser welding or other processes. Whenthe joining process is complete, the chamfered area at the distal end ofthe inner tubular member 2514 may be filled in. FIGS. 25S & 25Tillustrates additional details of the inner tubular member 2514. FIG.25U illustrates additional details of a ball detent mechanism 2599.Individual components or subassemblies of this embodiment may be usedwith any other embodiment disclosed herein. For example, additionalfigures described below, including but not limited to FIGS. 26A-26F,27A-27D, 28A-28D, 29A-29C, and 31A-31D, focus on a proximal portion of apolypectomy device (e.g., the handle portion), but any of those designsmay be used with the distal portion of a polypectomy device shown inFIGS. 25A-25U (e.g., including the inner and outer tubular bodies andcutting portions near the distal end).

The polypectomy device 2500 is similar in many respects to thepolypectomy device 100 described above, and similar reference numbersare used to refer to similar items. Further, for efficiency, thedescriptions given herein for this and other following embodiments arefocused on differences from the embodiments described above. Thepolypectomy device 2500 comprises several differences from theembodiments described above, and particularly the polypectomy device 100illustrated in FIG. 1A.

Rotatable Outer Tubular Member

One difference is that, in the polypectomy device 2500, the outertubular member 2504 is configured to be rotatable about the longitudinalaxis of the device with respect to the handle 102. Allowing rotation ofthe outer tubular member 2504 with respect to the handle 102 can bebeneficial in some embodiments, because this can allow rotationalpositioning of the opening 2508 in the distal end of the device withoutrotating the handle 102. Accordingly, if a doctor wishes to position thehandle 102, and the actuating member or trigger or knob 112 in aparticular orientation that is most comfortable and/or controllable forthat doctor, the doctor can do so, and then rotate the outer tubularmember 2504 with respect to the handle 102 to achieve a rotationalorientation of the opening 2508 that is most desirable for removal ofthe present polyp.

In this embodiment, rotation of the outer tubular member or outertubular body 2504 is desirably accomplished by rotating a hub 2591 whichis affixed to the outer tubular member 2504 and rotationally coupled tothe main body of the housing 102. In this embodiment, the hub 2591comprises a protruding shaft 2593 that fits into a corresponding hole2595 of the main body of the handle 102. The shaft 2593 is desirablysized to have a slip fit with the hole 2595, thus enabling rotationabout the longitudinal axis of the hub 2591 with respect to the mainbody of the handle 102. Further, a retaining ring or pin 2597 isdesirably utilized to limit translation along the longitudinal axis ofthe hub 2591 with respect to the handle 102. Some embodiments mayfurther comprise a bearing, sleeve, and/or the like operativelypositioned between the main body of the housing 102 and the shaft 2593to reduce friction between the hub 2591 and handle 102 and/or to allowmore controlled rotation. Further, other embodiments may utilize othermechanical methods of enabling rotation of the outer tubular member 2504with respect to the handle 102.

In this embodiment, the hub 2591 comprises a radially protruding member2592 that comprises a plurality of concave depressions desirably sizedfor engagement by a human finger. For example, the radially protrudingmember 2592 and/or its plurality of concave depressions may enable auser of the device to place his or her thumb on the radially protrudingmember 2592 and press sideways to cause rotation of the radiallyprotruding member 2592, and thus the hub 2591 and outer tubular member2504. Although such a design can be relatively ergonomic, various otherembodiments may comprise various other types of protruding members,knurled or other friction-increasing surfaces, and/or the like thatenable a user to use his or her fingers to cause rotation of the outertubular member 2504. Further, some embodiments may comprise a geartrain,linkage mechanism, and/or the like configured to transform motion of atrigger, button, and/or the like into rotational motion of the outertubular member 2504.

Although it can be desirable to enable rotation of the outer tubularmember 2504 with respect to the main body of the handle 102, it can alsobe desirable to selectively restrict such rotation, such as to avoidinadvertent rotation of the outer tubular member 2504 with respect tothe handle 102 during use. The present embodiment accomplishes such afeature by including a ball or pin detent mechanism 2599. In thisembodiment, with reference to FIG. 25U, the ball detent mechanism 2599comprises a spring-loaded ball or plunger 3198 that extends at leastpartially beyond a proximal surface of the hub 2591, and a plurality ofdetents, depressions, grooves, and/or the like 3194 in a distal surfaceof the housing 102. The spring-loaded ball or plunger 3198 can be heldat least partially within one of the detents, depressions, grooves,and/or the like 3194 under its internal biasing force (e.g., a spring3196 operatively positioned between the ball and the hub), which cankeep the outer tubular member 2504 in a specific rotational orientationwith respect to the handle 102 until a sufficient rotational force isapplied to force the ball or plunger 3198 out of the detent 3194.Although FIG. 25U shows only one of the plurality of detents 3194, thehousing 102 may comprise a plurality of detents 3194 similar to as shownin FIG. 31D.

Although this embodiment uses a ball detent mechanism to selectivelylimit rotation of the outer tubular member 2504 with respect to thehandle 102, other mechanisms may be used in lieu of a ball detentmechanism or in addition to a ball detent mechanism. For example, acollet type mechanism may be used that enables a user to flip a lever,rotate a member, and/or the like, to unlock rotational movement of theouter tubular member 2504 with respect to the housing 102, and thenreverse the movement of that lever, member, and/or the like to relockthe rotational orientation of the outer tubular member 2504 with respectto the handle 102. Such an embodiment may allow a firmer or stifferlocking of the rotation of the outer tubular member 2504 than a detenttype mechanism. However, a detent type mechanism may be desirablebecause it may be simpler for a user to use.

One reason a rotatable outer tubular member 2504 may be more desirablein the present embodiment than in the embodiment illustrated in FIGS. 1Aand 1B is that the present embodiment comprises a single opening 2508,whereas the embodiment illustrated in FIG. 1B comprises two openings108. With an embodiment that has more than one opening in the distalend, less rotation of the outer tubular member may be needed in order toalign any particular opening with a particular polyp. However, asdiscussed above, there can also be benefits to having only one openingin the distal end, such as to allow more precise control of aspiration.By including a single opening 2508, but also including the ability ofthe outer tubular member 2504 to rotate with respect to the handle 102,a polypectomy device with relatively fine control of aspiration andrelatively easy alignment of the opening with a polyp can be provided.

Alternative Cutting Block

Another difference of the polypectomy device 2500 with respect to thepolypectomy device of FIG. 1A is the use of a cutting block 2560 at thedistal end. The configuration of the cutting block 2560 is illustratedin the outer tubular member assembly views of FIGS. 25H and 251, and theindividual views of the cutting block 2560 in FIGS. 25J through 25L. Thecutting block 2560 is somewhat similar to the cutting block 1060described above with reference to FIGS. 10A through 10G. One differencewith the cutting block 2560, however, is that the cutting block 2560comprises a blunt rounded distal surface 2581 that is configured to bethe distal tip of the polypectomy device after the cutting block 2560 isassembled into the distal end of the outer tubular member 2505illustrated in FIGS. 25M and 25N. Such a configuration can be easier andcheaper to manufacture, and can also result in a smoother, lesstraumatic distal tip of the polypectomy device. This can be desirable,for example, to reduce the chance of trauma when the distal tip of thepolypectomy device contacts uterine tissue during a polypectomyprocedure.

With reference to FIG. 25K, the cutting block 2560 further comprises acylindrical surface 2583 sized to fit within and be coupled to an innerdiameter of the outer tubular member 2505 illustrated in FIG. 25N. Thecylindrical surface 2583 may in some embodiments comprise a press fit tohold the two components together. In some embodiments, the twocomponents may be held together with adhesive, a threaded junction,laser welding, and/or the like.

The cutting block 2560 further comprises a proximal cylindrical surface2585 that is sized to fit within the inner diameter of the outer tubularmember 2505, and create an annular shaped gap between the cylindricalsurface 2585 and the inner surface of the tubular member 2505. Thisannular shaped gap or void is labeled element 2587 in FIG. 25I.Similarly to as shown in FIG. 10G as described above, the inner tubularmember and/or tubular cutter at the end of the inner tubular member canbe sized to fit around the cylindrical surface 2585 and pass into thegap or void 2587 to help with separating polyp tissue. In someembodiments, it can be desirable to control a clearance between theouter surface 2585 of the cutting block 2560 and the inner surface ofthe inner tubular member or cutter (e.g., inner surface 2586 illustratedin FIG. 25R). A tighter clearance may help to efficiently separate polyptissue, while too tight of a clearance could lead to jamming of thetool. In some embodiments, it is desirable to have a diametral clearancebetween the inner surface 2586 and outer surface 2585 (i.e. the diameterof the inner surface 2586 minus the diameter of the outer surface 2585)within a range of 0.0005-0.0015, 0.001-0.002, 0.001-0.003, or0.002-0.005 inches. In some embodiments, it can be desirable to have arelatively deep gap or void 2587 (measured in the longitudinal directionas the longitudinal depth beyond the distal edge of the opening 2508). Arelatively deep gap or void 2587 can increase the likelihood of polyptissue being completely and efficiently severed, by allowing the cuttingend of the inner tubular body to move beyond the distal edge of theopening 2508. In some embodiments, it is desirable for the gap or void2587 to have a longitudinal depth that is at least 25%, 30%, 40%, 50%,60%, 70%, 80%, 90%, or 100% of the inner diameter of the outer tubularbody.

The cutting block 2560 further comprises a circular shaped cutting edge2589 at the junction between the proximal most edge of the outercylindrical surface 2585 and a proximal concave surface 2571. Althoughsome embodiments may comprise a flat (or other shaped) proximal surface,instead of the concave proximal surface 2571, the concave proximalsurface 2571 can help to create a sharper cutting edge 2589 that caninteract with the inner tubular member and/or tubular cutter attached tothe distal end of the inner tubular member to sever or shear polyptissue. It may be desirable to utilize a proximal concave surface 2571having a spherical radius within a range of 0.100-0.200 or 0.150-0.250inches. In some embodiments, a ratio of the spherical radius of theproximal concave surface 2571 divided by the outer diameter of the outercylindrical surface 2585 is desirably within a range of 1.0-2.0,1.5-2.0, or 1.0-3.0. Although in this example embodiment the sharpenedcutting edge 2589 is created by the junction of the outer surface 2585and a concave spherical surface, other embodiments may create asharpened cutting-edge 2589 in various other ways.

Another difference in the cutting block 2560 with respect to the cuttingblock 1060 is that the cutting edge 2589 lies in a plane that issubstantially perpendicular to the longitudinal axis of the tool. In theembodiment illustrated in FIG. 10E, however, the proximal surface of thecutting block 1060 is angled at angle 1062 with respect to a plane thatis perpendicular to the longitudinal axis. Both designs can help to cutpolyp tissue. One benefit of the design illustrated in FIG. 25K,however, is that it may be easier and/or cheaper to manufacture acutting block that has a round cutting-edge 2589 created by adding theconcave proximal surface 2571. Further, with reference to FIG. 25I, inthis embodiment, the proximal cutting edge (e.g., cutting edge 2589shown in FIGS. 25K and 25L) of the cutting block 2560 can be recesseddistally beyond the distal edge of the opening 2508, helping to maximizethe use of space within the tool and/or to position the distal end ofthe opening 2508 closer to the distal tip of the polypectomy device.Other embodiments may have the proximal cutting edge approximatelyaligned with the distal edge of the opening 2508, or may have theproximal cutting edge extend somewhat longitudinally proximately intothe opening area 2508. Further, some embodiments may have the cuttingedge 2589 oriented at a non-perpendicular angle with respect to thelongitudinal axis, such as any of the angles discussed above withrespect to cutting block 1060.

Spring-Loaded Cutter

Another difference in the polypectomy device 2500 is that thepolypectomy device 2500 comprises a spring-loaded cutter release ordisconnect mechanism 2570 illustrated in the detail cross-sectional viewof FIG. 25D and also partially in FIGS. 25E through 25G. Thespring-loaded cutter release mechanism 2570 is desirably configured toenable the inner tube assembly 2590 illustrated in FIG. 25O toautomatically move forward with respect to the outer tubular member inresponse to the actuating member or trigger 112 being pulled beyond apredetermined point (or otherwise being activated, such as describedbelow in reference to other spring-loaded embodiments). It can bedesirable in some embodiments to allow the inner tube and/or the cutterintegrated into or coupled to the distal end of the inner tube to moveor extend with respect to the outer tube in a relatively quick fashionto aid in cutting polyp tissue. As an example, with reference to FIG.25D, the spring-loaded cutter release or disconnect mechanism 2570comprises a trigger 112 having an actuator link 2571 rotatably coupledthereto. In this embodiment, the actuator link 2571 is rotatably coupledto the trigger 112 via the pin 2572. The actuator link 2571 is desirablybiased in a downward or clockwise direction in this embodiment (e.g., adirection toward engagement with actuation surface 2575 of actuationmember 2576, as described below) by a torsion spring 2573. By biasingthe actuator link 2571 downward or in a clockwise direction, this causesa protruding member or catch portion 2574 to engage a distal surface oractuation surface 2575 of an actuation member 2576. The actuation member2576 is desirably coupled to the inner tubular member 2514. Accordingly,with continued reference to FIG. 25D, if the trigger 112 is translatedin a proximal or retraction direction (to the left as oriented in FIG.25D), the catch portion 2574 will cause the actuation member or block2576 to also translate to the left or in the retract direction alongwith the trigger 112. Once the trigger 112 is translated in the retractdirection a sufficient amount, the bottom surface 2577 of the actuatorlink 2571 will engage a ramp or cam portion 2578 of the handle 102.Continued translation of the trigger 112 in the retract direction willcause the ramp 2578 to force the actuator link 2571 upward or in acounterclockwise direction (e.g., a direction away from engagement withactuation surface 2575). Once the actuator link 2571 rotatessufficiently in the counterclockwise direction, the catch portion 2574will no longer engage the actuation surface 2575 of the actuation member2576, and the actuation member 2576 and inner tubular member 2514 willdesirably spring forward in the extended direction under the biasingforce of the spring 2579 (which is operably positioned between thehandle 102 and the actuation member 2576).

The ramp or cam portion 2578 and the bottom surface 2577 of the actuatorlink 2571 are desirably designed such that the catch portion 2574 willrelease the actuation member 2576 when the trigger 112 has been moved apredetermined distance. The predetermined distance that results inreleasing the actuation member 2576, and thus springing the cutterforward, can desirably be selected based on a desired position of thedistal end of the inner tubular body and/or the cutting edge 2552 of thetubular cutter with respect to the opening 2508. For example, it may bedesirable for the predetermined distance to be selected such that thecutting edge 2552 will be retracted such that it is in line with theproximal end of the opening 2508, or even behind (or proximal to) theproximal end of the opening 2508 before springing forward. Such designsmay be desirable, because they can enable the full length of the opening2508 to be accessible for tissue to be inserted therethrough beforespringing the cutter forward. In some embodiments, it may be desirableto design the cam or ramp portion 2578 and bottom surface 2577 such thatthe predetermined distance that results in springing the cutter forwardwill occur before the cutting edge 2552 of the tubular cutter reachesthe proximal end of the opening 2508. For example, the opening 2508comprises a length in the longitudinal direction, and it may bedesirable to set the predetermined distance such that a longitudinaldistance from the proximal end of the opening 2508 to the cutting edge2552 when the disconnect mechanism releases the inner tubular body is nogreater than ⅓, ¼, or ⅛ of the longitudinal length of the opening. Sucha design may be desirable, for example, because not retracting thecutting edge 2552 completely to the proximal end of the opening 2508 mayhelp to avoid clogging by potentially cutting off smaller pieces ofpolyp tissue than if the cutting edge 2552 were retracted all the way toor beyond the proximal end of the opening 2508. It should be noted that,although this disclosure regarding the design of the disconnectmechanism to release the cutter when the cutting edge of the tubularcutter reaches a particular position with respect to the opening isdescribed with reference to the embodiment of FIGS. 25A-25T, the samedesign considerations and predetermined distances may apply to otherdisconnect mechanisms described herein. For example, the disclosureregarding designing the ramp or cam surface 2578 and bottom surface 2577to release the mechanism when the cutter is in a particular position mayalso apply to the cam surfaces 3178 and bottom or angled surfaces 3177described below.

The user can then move or allow the trigger 112 to move back to astarting position as shown in FIG. 25D, where the catch portion 2574will be forced downward or rotated in a clockwise direction by thetorsion spring 2573 and reengage the distal surface 2575 of theactuation member 2576. In some embodiments, a biasing member, such as aspring, is used to automatically return the trigger 112 to its forwardor starting position (for example, similar to spring 3153 of theembodiment shown in FIG. 31B). To allow clearance for the catch portion2574 to re-engage with the distal surface 2575 of the actuation member2576, the actuation member 2576 further comprises a distally extendingprotrusion 2569 that stops the actuation member 2576 from translatingfar enough in the extend direction that there would not be room left forthe catch portion 2574 to engage the distal surface 2575.

This embodiment illustrates merely one example of a spring-loaded cutterrelease mechanism, which may also be known as a disconnect mechanism,that enables selective and/or automatic disconnecting or decoupling ofthe inner tubular member from the trigger. Somewhat similarfunctionality could potentially be accomplished by using an embodimentlike the embodiment shown in FIG. 1A, and having the user simply removehis or her finger from the trigger after pulling the trigger back,allowing the spring to return the trigger and inner tubular member to anextended position. It can be desirable, however, to automate thisrelease of the inner tubular member with a disconnect or decouplingmechanism, because it can be easier for a user to operate and can alsoallow or enable faster extension of the inner tubular member. Forexample, by disconnecting or decoupling the trigger 112 from the innertubular member 2514, there is less mass for the spring 2579 toaccelerate forward in the extension direction. Accordingly, a spring2579 will desirably move the inner tubular member 2514 to the extendedposition more quickly when the inner tubular member 2514 has beendecoupled from the trigger 112 than if the inner tubular member 2514were not decoupled from the trigger 112. As a non-limiting example, anembodiment that does not decouple the trigger from the inner tubularmember may have an extension speed of approximately 20 inches/second,and a similar embodiment that does decouple the trigger from the innertubular member may have an extension speed of approximately 65inches/second. Such an increase in speed may help to more efficientlyand/or more cleanly cut polyp tissue. In some embodiments, it can bedesirable to have a higher spring rate for the spring 2579 to increasethe speed of extension of the inner tubular member 2514 when released.In some embodiments, it can be desirable for the spring 2579 to comprisea spring rate that is approximately, no greater than, or no less than 1,2, 3, 4, 4.5, 5, or 6 pounds/inch. In some embodiments, it can bedesirable for the spring 2579 to comprise a spring rate within the rangeof 2.5-3.5 pounds/inch. In some embodiments, it can be desirable toprovide a mechanism for cocking or moving the assembly to the retractedposition that provides a mechanical advantage, instead of requiring auser to directly apply such axial force. For example, as will bedescribed in more detail below with respect to the embodimentsillustrated in FIGS. 27A-27D, 28A-28D, 29A-29C, and 31A-31D, someembodiments may comprise a trigger that utilizes a linkage mechanism, agear train, and/or the like to provide a mechanical advantage. Suchembodiments of trigger mechanisms may be used with all other features ofthe embodiment of FIGS. 25A-25T. In some embodiments, such mechanicaladvantage is configured to be approximately, exactly, no less than, orno greater than 1.5, 2.0, 2.5, or 3.0.

In some embodiments, it may be desirable to include a damping feature todampen a shock load imparted into the inner tubular member assemblyand/or handle at the end of the extension stroke. For example, ano-ring, gasket, or other resilient member may be positioned between thedistally extending protrusion 2569 and a corresponding mating surface ofthe housing 102.

Various other methods of decoupling the inner tubular member from thetrigger or actuating member may be used, and some of these other methodsare described below with reference to additional figures. Further,although various embodiments described herein describe a spring-loadedcutter that springs forward (e.g., toward the distal end of the device),similar features may be used with a cutter that springs backward (e.g.,toward the proximal end of the device. For example, such a design couldbe used with a cutter similar to as shown in FIGS. 9C-9E, which cutspolyp tissue as the cutter is retracting. For example, a spring could beused to bias the cutter in the retracted direction, and movement of theactuating member or trigger by the user could cause the cutter to movein the extend direction, until the disconnect mechanism releases thecutter to allow it to spring back. Accordingly, the disconnect mechanismdesign could be essentially the opposite of the designs shown in FIGS.25B, 26E, 27B, 28B, 29C, and 31B. One reason such a design may bedesirable is that the cutter would be moving in the same direction asthe vacuum pressure (which would be pulling the polyp tissue toward theproximal end of the device), which may help to produce larger specimenswith each cut.

Spring-Loaded Cutter with Rotation

FIGS. 26A-26F illustrates an example embodiment of a mechanism for apolypectomy device that incorporates a spring-loaded release ordecoupling feature for the cutting tube or inner tubular member 2614,and also incorporates an automatic rotation mechanism that causes theinner tubular member 2614 to rotate with respect to the outer tubularmember 2604 as the inner tubular member 2614 is also translating withrespect to the outer tubular member 2604. Incorporating at least somerotation of the inner tubular member 2614, and thus the cutting blade orsurface at the distal end of the inner tubular member 2614, can help tomake an efficient cut in the polyp tissue as the inner tubular member2614 translates forward with respect to the outer tubular member 2604.One reason for this increase in cutting efficiency is that the absolutespeed of the cutting edge of the inner tubular member 2614 with respectto a corresponding cutting surface coupled to or formed by the outertubular member 2604 may be increased. Another reason for this increasein cutting efficiency is that the rotation in combination withtranslation can tend to lead to more of a slicing action than withsimply a translation motion.

The embodiment illustrated in FIGS. 26A-26F is a simplified designintended to show how such a decoupling and rotation mechanism 2670 mayoperate. Accordingly, the housing 102 is merely a rectangular box, butin other embodiments could comprise an ergonomic handle as illustratedin some of the other embodiments illustrated herein. Further, thedecoupling and rotation mechanism 2670 comprises a trigger 112 that canbe manually cocked and then manually released by a user pressing release2612 (for example, a lever, button, trigger, latch, and/or the like). Itmay be more desirable, however, in some embodiments, to have the innertubular member automatically release when the trigger 112 reaches acertain point, similar to as described above with respect to thepolypectomy device 2500. In this simplified example, however, theassembly is cocked by a user sliding the trigger 112 in a retractiondirection until a catch 2605 engages a corresponding catch 2606 of therocker or latch 2612. In doing so, spring 2613 is compressed. When auser manipulates the rocker or latch 2612, the catches 2605, 2606 willdisengage, enabling the spring 2613 to push the trigger 112 in theextend direction, thus also translating the inner tubular member 2614 inthe extend direction with respect to the outer tubular member 2604. Insome embodiments, including this embodiment and others disclosed herein,the spring that biases the inner tubular body forward (e.g., spring2613) may be positioned against a spring seat (e.g., spring seat 2615)that is adjustable (for example, slidable in the longitudinal direction)to adjust the preload force of the spring. Additionally oralternatively, the spring may be replaced with a spring having adifferent spring rate and/or length to adjust the preload force of thespring.

Another feature of the decoupling and rotation mechanism 2670 is thatthe mechanism comprises a body 2620 coupled to the inner tubular member2614. The body 2620 comprises a helical cam groove 2621 having a pin2622 positioned therein. The pin 2622 is desirably held stationary withrespect to the housing (not shown in FIGS. 26C and 26D for clarity).Accordingly, when the inner tubular member 2614 and attached body 2620are forced forward by the spring 2613, the body 2620 and inner tubularmember 2614 will also be caused to rotate with respect to the outertubular member 2604 as the pin 2622 tracks the path of the helical camgroove 2621. In some embodiments, the pin 2622 is coupled to the innertubular member 2614 and tracks a groove that is coupled to or part ofthe housing (essentially the opposite of the configuration shown inFIGS. 26C and 26D). This can enable less rotational mass, and thuspotentially faster movement of the inner tubular member 2614. Further,some embodiments may comprise more than one pin (or equivalent feature),such as two, three, or four pins equally spaced about the inner tubularmember 2614 or body 2620.

In some embodiments, it can be desirable for the helical cam groove 2621to have a relatively high lead or pitch. For example, it can bedesirable for the helical cam groove 2621 to have a lead or pitch thatcauses the inner tubular member 2614 to rotate only 180° as the innertubular member 2614 translates from a fully retracted position to afully extended position. Using such a relatively high pitch or lead canreduce friction, thus enabling the inner tubular member 2614 totranslate and/or rotate faster. In various embodiments, the helical camgroove 2621 may be configured to cause the inner tubular member 2614 torotate or partially rotate a smaller or greater amount as the innertubular member moves from the fully retracted to the fully extendedposition, such as, for example, approximately, no less than, or no morethan 45, 90, 135, 180, 225, 270, 315, or 360°. In some embodiments, thedevice is configured to cause the inner tubular member 2614 to rotatewithin a range of 160-200 degrees, 90-270 degrees, or 45-315 degrees asthe inner tubular member moves from the fully retracted to the fullyextended position. Further, some embodiments may comprise a variablepitch or lead, or even a non-helical groove. For example, someembodiments may comprise a groove shaped such that the inner tubularmember rotates back and forth, such as at least once in a clockwisedirection and at least once in a counterclockwise direction, as theinner tubular member extends from the fully retracted position to thefully extended position. In some embodiments, the body 2620 may comprisea material configured to reduce the friction between the cam groove 2621of the body 2620 and the pin 2622. For example, the body 2620 maycomprise an acetal polymer that has Polytetrafluoroethylene (PTFE)formulated into it. Further, some embodiments may comprise a grease,oil, bearing, and/or the like to reduce such friction. Some embodimentsmay comprise a lead screw coupled to a lead nut to cause rotation of theinner tubular member when the inner tubular member translates.

Alternative Automatic Decoupling Mechanisms

FIGS. 27A-27D, 28A-28D, and 29A-29C illustrate three alternativeembodiments of automatic decoupling or release mechanisms 2770, 2870,and 2970, respectively. These automatic decoupling mechanisms desirablyoperate on a similar principle to the automatic decoupling mechanism2570 illustrated in FIG. 25D, but with different trigger configurations.Further, any of these automatic decoupling mechanism may compriseautomatic rotation features as described above with reference to FIGS.26A-26F. The automatic decoupling mechanisms 2770, 2870, and 2970 eachcomprises a trigger 112 that is rotatably or pivotally coupled to thehandle 102 at pivot axis 2780 instead of being slidably coupled to thehandle 102. Accordingly, instead of a user sliding a trigger 112 in theretract direction to cause the inner tubular member 2514 to move in theretract direction, a user can squeeze the trigger 112 to cause the innertubular member 2514 to move in the retract direction. Such aconfiguration may in some cases be more ergonomic than a slidingtrigger. Such a configuration may also enable a greater mechanicaladvantage than a sliding trigger.

With reference to FIG. 27B, the decoupling mechanism 2770 comprises anactuator link 2771 that has a spring-loaded or elastically bendableconnecting link or portion 2772 that engages a catch 2775 of actuationmember 2576. As the trigger 112 is squeezed, linkage 2760, which ispivotally coupled to the trigger 112 and the actuator link 2771, causesthe actuator link 2771 to be pulled in the retract direction, thuscausing catch 2775 and actuation member 2576 to also be pulled in theretract direction. This also causes the inner tubular member 2514 to bepulled in the retract direction. As the actuator link 2771 is pulled inthe retract direction, a bottom or angled portion 3177 of the bendableconnecting link 2772 will desirably engage a cam surface or ramp 3178coupled to or integrated into an interior of the handle 102. As theactuator link 2771 continues to be pulled in the retract direction, thecam surface 3178 will eventually force the bendable portion 2772 outward(e.g., away from the actuation member 2576) and out of engagement withthe catch 2775, thus decoupling the trigger 112 from the actuationmember 2576 and inner tubular member 2514. This can allow the spring2579 to release or launch the inner tubular member 2514 forward or inthe extension direction. FIG. 27D illustrates a configuration where thetrigger 112 has been fully compressed. In this case, the spring-loadedportion 2772 is still shown to be engaging the catch 2775. However,desirably, as described above, in this position of the trigger 112, thecam surface 3178 will have moved the bendable portion 2772 out ofengagement with the catch 2775. The bendable portion 2772 in this andother embodiments may comprise spring steel, plastic, or anothermaterial having sufficient elasticity to be bent out of engagement withthe catch 2775 without plastic deformation.

With continued reference to FIG. 27B, the bendable portion 2772 furthercomprises another bottom or angled surface 3179 positioned to engage camsurface 3180 of the actuation member 2576. The angled surface 3179 andcam surface 3180 are positioned to cooperate to push the distal end ofbendable portion 2772 up and over the catch 2775 to allow the bendableportion 2772 to re-engage the catch 2775 as the trigger 112 is released.The bendable portion 2772 may engage the catch 2775 similar to as shownin FIG. 31C, described below.

The embodiment illustrated in FIGS. 29A-29C, namely the decouplingmechanism 2970, is similar in design to the embodiment 2770 illustratedin FIGS. 27A-27D, with similar reference numbers used to refer tosimilar elements. Some differences in the embodiment of the decouplingmechanism 2970 are that the housing and trigger 102, 112 comprise adifferent shape, and the actuator link 2971 is coupled to linkage 2760at a different point. In this embodiment, linkage 2760 is pivotallycoupled to the actuator link 2971 at a point forward of a proximallyprotruding member 2972 (instead of at a proximal end of the actuatorlink), which can change the mechanical advantage provided by the linkage2760. Further, the embodiment illustrated in FIGS. 29A-29C includes abody 2620 similar to as described above with reference to FIGS. 26A-26F,to cause rotation of the inner tubular body as it extends.

FIGS. 28A-28D illustrate another alternative embodiment of a disconnectmechanism 2870. This mechanism is somewhat similar to the disconnectmechanism 2770, with similar reference numbers used to refer to similarelements, but using a gear driven mechanism instead of a linkagemechanism to convert rotational motion of the trigger 112 intotranslational motion of the actuator link 2871. In this embodiment, whenthe trigger 112 is squeezed, this causes a first gear 2865 to rotate asecond gear 2866, which causes translation or sliding of a gear rack2867. With reference to FIG. 28B, if the trigger 112 is squeezed (i.e.rotating counterclockwise as shown in FIG. 28B), the gear 2866 will becaused to rotate clockwise and thus move the rack 2867 to the right, orin the retracted direction. The rack 2867 is pivotally coupled to theactuating link 2871 at their proximal ends, thus causing the actuatinglink 2871 to also move in the retract direction. In this embodiment,once the actuating link 2871 has been retracted sufficiently, the bottomsurface 3177 of the actuating link 2871 will desirably contact a camsurface, ramp, or equivalent feature 3178 coupled to the housing 102that will cause the catch portion 2574 to disengage or decouple from theactuation member 2576, thus allowing the inner tubular member 2514 toautomatically extend forward under the energy of the spring 2579. FIG.28D shows the fully compressed trigger position, except that theactuating link 2871 would be lifted up away from the actuating member2576 instead of still engaging the actuating member 2576. Returning toFIG. 28B, the actuating member 2576 further comprises a cam surface 3180that can push the catch 2574 up and over the actuating member 2576 asthe trigger is released from the compressed position, thus allowing thecatch 2574 to re-engage the actuating member 2576 when the trigger 112is in the extended position.

Alternative Openings

FIGS. 30A-30C, 32A-32C, and 33A-33D illustrate alternative embodimentsof outer tubular members 3004, 3204, and 3304, respectively, that couldbe used with any of the embodiments disclosed herein, including theembodiment of the outer tubular member assembly 2504 illustrated inFIGS. 25H and 251 and other figures. With reference to FIGS. 30A-30C,one difference of the outer tubular member 3004 with respect to theouter tubular member 2505 of FIG. 25H is that the outer tubular member3004 comprises an opening 3008 having a distal cutting surface 3009 thatis angled or inclined with respect to a transverse plane (for example, aplane oriented perpendicular to the longitudinal axis of the outertubular member). In this embodiment, the distal cutting surface 3009 isoriented at an approximately 30° angle A with respect to the transverseplane; however, other embodiments could position the distal cuttingsurface 3009 at a different angle A, such as, for example,approximately, exactly, no less than, or no more than 10, 20, 30, 40,50, 60, 70, or 80°. In some embodiments, the angle A may be within arange of 10-50°, or 20-40°.

Further, some embodiments may comprise a distal cutting surface that iscurved, rounded, radiused, and/or the like, instead of being positionedat a specific angle. For example, FIGS. 32A-32C illustrate anotherexample embodiment of an outer tubular member 3204 that is similar tothe outer tubular member 3004 except for the design of the opening 3208.In this embodiment, the outer tubular member 3204 comprises a distalcutting surface 3209 that is rounded when viewed perpendicular to thelongitudinal axis of the outer tubular body and normal to a center ofthe opening 3208, for example as oriented in FIG. 32B. In thisembodiment, the distal cutting surface 3209 comprises a single convexrounded shape when viewed perpendicular to the longitudinal axis andnormal to the center of the opening 3208. Other embodiments may comprisemultiple rounded shapes and/or concave shapes instead of convex shapes.For example, FIGS. 33A-33D illustrate another example embodiment of anouter tubular member 3304 that is similar to the outer tubular member3004 except for the design of the opening 3308. In this embodiment, theouter tubular member 3304 comprises a distal cutting surface 3309 thatcomprises a plurality of concave rounded surfaces when viewedperpendicular to the longitudinal axis of the outer tubular member 3304and normal to a center of the opening 3308, for example, as oriented inFIG. 33B. The design shown in FIG. 33B, which includes a plurality ofconcave surfaces, also results in a plurality of pointed portions 3310that can help with severing of tissue more efficiently.

Returning to FIG. 32A, the outer tubular member 3204 further comprises arecess 3211 when viewed perpendicular to the longitudinal axis and fromthe side of the opening 3208, for example, as oriented in FIG. 32A. Therecess 3211 is at least partially defined by the distal cutting surface3209 extending into the opening 3208 at an angle B. In this embodiment,the angle B is approximately 45°. In other embodiments, however, theangle B may be approximately, no greater than, or no less than 20°, 30°,40°, 50°, 60°, or 70°. In some embodiments, the angle B may be within arange of 30 to 600. The recess 3211 may help to form the rounded cuttingsurface 3209 into a shape that can help with severing of tissue moreefficiently. It may be desirable to have a distal cutting surface of theopening that is angled, rounded, or otherwise not parallel with atransverse plane to, for example, help with severing of tissue moreefficiently. The embodiments disclosed herein, including the embodimentsshown in FIGS. 30A-30C, 32A-32C, and 33A-33D, may further help toprevent the polyp tissue from slipping out of the cutting bay (e.g., theopening 3008, 3208, 3308) once the cutter tube (e.g., tubular cutter2515) strikes the tissue. For example, the distal cutting surface 3009,3209, 3309 may help to “capture” the tissue between the distal cuttingsurface and the tubular cutter, to prevent the tubular cutter frompushing the tissue out of the opening as the tubular cutter strikes thetissue.

Further, the angular width of the openings 3008, 3208, 3308, or anyother outer tubular member openings disclosed herein, may comprisevarious values. For example, with reference to the discussion aboveregarding angle 636 shown in FIG. 6D, the same range of angular widths636 may apply to the openings 3008, 3208, 3308, or any other outertubular member openings disclosed herein. For example, the openings3008, 3208, or 3308 may comprise an angular width, as defined above withrespect to angular widths 636, that is approximately, exactly, nogreater than, or no less than, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°,70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°,135°, 140°, 145°, 150°, 155°, 160°, 170°, 180°, 190°, 200°, 210°, 220°,230°, 240°, 250°, 260°, or 270°. In some embodiments, it may bedesirable to have an opening having an angular width greater than 90°,such as 120°, 150°, 180°, or any of the other angles given above, toincrease the size of polyp tissue that may pass through the opening andbe severed at any one time, thus increasing the efficiency of thepolypectomy device. In some embodiments, it may be desirable to have anangular width of the opening that is within a range of 100°-140°.Testing results confirm such a desirable range, as shown in the twotables below, which compare the size of cut (in grams/cut) for a devicewith a 120 degree opening (Table 1) and a device with a 90 degreeopening (Table 2).

TABLE 1 Device Configuration: 120° window (e.g., angle 636), bladerotation (e.g., rotation of the inner tubular member with respect to theouter tubular member as the inner tubular member moves from theretracted to extended position), 30° blade grind (e.g., the chamferangle A shown in FIG. 25Q, measured with respect to a longitudinalplane), 3 lbf/in spring (e.g., the spring 2579, 3151, or the like) Trial1 2 3 4 5 6 Number of Cuts 23 35 34 24 24 20 Grams/Cut 0.21 0.12 0.080.23 0.10 0.20

TABLE 2 Device Configuration: 90° window (e.g., angle 636), bladerotation (e.g., rotation of the inner tubular member with respect to theouter tubular member as the inner tubular member moves from theretracted to extended position), 30° blade grind (e.g., the chamferangle A shown in FIG. 25Q, measured with respect to a longitudinalplane), 3 lbf/in spring (e.g., the spring 2579, 3151, or the like) Trial1 2 3 4 5 6 Number of Cuts 32 41 37 40 41 37 Grams/Cut 0.04 0.06 0.070.06 0.10 0.08

The efficiency of the polypectomy device can in some embodiments also beincreased by changing the angle and/or direction of the chamfer thatforms the distal cutting edge of the tubular cutter of the inner tubularmember. For example, with reference to FIG. 25Q, the tubular cutter 2515in this embodiment comprises an approximately 22.5° chamfer 1554(measured with respect to a longitudinal plane at angle A) that formsthe distal cutting edge 2552. In other embodiments, this angle A may belower or higher (measured with respect to a longitudinal plane). Forexample, this angle A may be approximately, exactly, no greater than, orno less than 45°, 40°, 30°, 22.5°, or 20°. In some embodiments, angle Amay be within a range of 40-50 degrees, 30-60 degrees, 18-26 degrees, or15-30 degrees. In some embodiments, this chamfered cutting edge isdesirably formed using a grinding process, to generate a sharper cuttingedge than typical machining processes. In some embodiments, asillustrated in FIG. 25Q, the tubular cutter is designed such that thecutting edge 2552 is positioned at an inner diameter of the tubularcutter. Stated another way, the chamfer 1554 that forms angle A ispositioned radially outward of the cutting edge 2552. Positioning thecutting edge 2552 inward of the chamfer 1554 and/or at the innerdiameter of the tubular cutter (as opposed to positioning the cuttingedge 2552 at a position radially outward of the inner diameter) can helpto increase the efficiency of the device and/or reduce clogging. This isbecause a cutting edge positioned more radially outward may producelarger diameter pieces of tissue, which may be harder to pass throughthe inner lumen of the tubular cutter 2515 and/or the inner tubularmember 2514. In this embodiment, the cutting edge 2552 comprises acircular cutting edge that is oriented such that the circle lies in aplane that is perpendicular to the longitudinal axis of the tubularcutter. Other embodiments may comprise differently shaped cutting edges,such an oval shaped cutting edge that is oriented such that the ovallies in a plane that is not perpendicular to the longitudinal axis ofthe tubular cutter.

Alternative Release Mechanism

FIGS. 31A-31D illustrate another example embodiment of an automaticdecoupling or release mechanism 3170 that can be used with any otherembodiments of polypectomy devices disclosed herein. For example, theembodiment illustrated in FIGS. 31A-31D may be used with the distal endconfiguration of the embodiment of FIGS. 25A-25U, or with any of theother distal end configurations disclosed herein. The mechanism 3170 issimilar in many respects to the mechanism 2970 illustrated in FIGS.29A-29C. Accordingly, similar reference numbers are utilized, and thisdescription focuses on differences in this embodiment with respect toother embodiments disclosed herein. The automatic decoupling or releasemechanism 3170 comprises a housing 102, with a pivotally coupled trigger112, and various components positioned within a cavity of the housing102. FIG. 31A illustrates an outer side view of the mechanism 3170, andFIG. 31B illustrates a similar view, but with internal components shownin hidden lines. FIG. 31C illustrates a perspective view, with thehousing 102 hidden. FIG. 31D illustrates a perspective view, with thehub 2591 hidden, to show a detent mechanism 3199.

One difference in the mechanism 3170 is the configuration of thebendable and/or spring-loaded connecting link or portion 2772, whichengages the catch 2775. In the embodiment illustrated in FIG. 29C, thebendable and/or spring-loaded connecting link 2772 is coupled toactuator link 2971. In the embodiment of FIG. 31B, however, the bendableand/or spring-loaded connecting link 2772 desirably comprises arelatively thin piece of spring steel (or any other material that canperform a similar function) that is affixed to a proximal body 3152using one or more fasteners 3154 (such as screws, rivets, and/or thelike). The proximal body 3152 is configured to move proximally (to theright as shown in FIG. 31B) when the trigger 112 is squeezed. Theproximal body 3152 is biased in the distal direction by proximal spring3153. The proximal body 3152 and distal body (or actuating member) 2576each comprise lateral protrusions 3160 configured to engage acorresponding channel or groove in the housing 102, to guide the slidingmotion of the bodies 3152, 2576 in the longitudinal direction.

The bendable connecting link 2772 is desirably configured such that theconnecting link 2772 engages the catch 2775 of the distal body 2576 whenthe proximal and distal bodies 3152, 2576 are in their distal mostpositions (as shown in FIG. 31B). As the proximal body 3152 istranslated proximally by squeezing of the trigger 112 (with forcetransmitted through linkage 2760), the connecting link 2772 causes thedistal body 2576 to also translate proximally. The distal body 2576 isdesirably coupled to body 2620, so that body 2620 also translatesproximally with distal body 2576. With continued squeezing of thetrigger 112, as described above with reference to other embodiments, thebottom surface 3177 of the bendable connecting link 2772 will desirablyengage cam surface 3178 of the housing, eventually forcing the distalportion of the connecting link 2772 to be forced upward and over thecatch 2775 of the distal body 2576. Once the connecting link 2772 hasdisengaged the catch 2775, the distal spring 3151 is configured to causethe distal body 2576 to spring forward or in the distal direction. Thiswill cause the inner tubular member 2514 to translate in the distaldirection. Further, the helical groove 2621 of the body 2620 willdesirably cause the inner tubular member 2514 to rotate about itslongitudinal axis as the inner tubular member 2514 springs forward. Thebody 2620 is desirably coupled to the distal body 2576 in a way thatallows rotation about the longitudinal axis of the body 2620 withrespect to the distal body 2576. Finally, as the user releases pressureon the trigger 112, the proximal spring 3153 will desirably push theproximal body 3152 back to its distal most position, causing theconnecting link 2772 to reengage the catch 2775. As described above withreference to other embodiments, bottom or angled surface 3179 of theconnecting link 2772 will cooperate with cam surface 3180 to facilitatethe distal end of the connecting link 2772 to move up and over the catch2775 to re-engage the catch. The device is then ready for the nextactuation. The proximal spring 3153 can be beneficial, for example,because it will allow the trigger 112 to be automatically “reset” to theextended position when a user released pressure from the trigger 112. Insome embodiments, the proximal spring 3153 comprises a smaller springrate than the distal spring 3151. This can be beneficial, for example,because the proximal spring 3153 is used to reset the trigger 112, whichmay be desired to be a less forceful and/or slower movement than thespringing forward of the inner tubular body. In some embodiments, adamping mechanism may be included to damp the motion of the trigger 112from the compressed to the extended position. It should be noted that,although this and other embodiments disclosed herein refer to a bendableportion that can elastically bend to engage or disengage a catch, any ofthese embodiments may also or alternatively comprise a portion thatrotates instead of bends to engage or disengage the catch (such as shownin the embodiment of FIG. 28B).

The embodiment illustrated in FIGS. 31A-3D also illustrates anotherembodiment of a detent mechanism 3199 to selectively restrict rotationof the outer tubular body with respect to the handle. Specifically, FIG.31D illustrates a portion of the handle 102 with the hub 2591 removedfor clarity. Similarly to the detent mechanism 2599, the detentmechanism 3199 comprises a spring-loaded plunger 3198 positioned atleast partially within the hub 2591 (not shown for clarity) and that canextend at least partially into one of a plurality of detents,depressions, grooves, and/or the like 3194 in a distal surface of thehousing 102. The spring-loaded plunger 3198 can be held at leastpartially within one of the detents, depressions, grooves, and/or thelike 3194 under its internal biasing force (e.g., a spring 3196operatively positioned between the plunger and the hub), which can keepthe outer tubular member 2504 in a specific rotational orientation withrespect to the handle 102 until a sufficient rotational force is appliedto force the ball or plunger 3198 out of the detent 3194. As with thedetent mechanism described above, other forms of selective anti-rotationof the outer tubular member 2504 may also be used.

Conditional language, such as, among others, “can,” “could,” “might,” or“may,” unless specifically stated otherwise, or otherwise understoodwithin the context as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements and/or steps areincluded or are to be performed in any particular embodiment. Theheadings used herein are for the convenience of the reader only and arenot meant to limit the scope of the inventions or claims.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Additionally, the skilled artisan will recognize that any ofthe above-described methods can be carried out using any appropriateapparatus. Further, the disclosure herein of any particular feature,aspect, method, property, characteristic, quality, attribute, element,or the like in connection with an embodiment can be used in all otherembodiments set forth herein. For all of the embodiments describedherein the steps of the methods need not be performed sequentially.Thus, it is intended that the scope of the present invention hereindisclosed should not be limited by the particular disclosed embodimentsdescribed above. The ranges disclosed herein also encompass any and alloverlap, sub-ranges, and combinations thereof. Moreover, language suchas “up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers or qualities orcharacteristics or amounts or quantities preceded by a term such as“approximately”, “about”, and “substantially” as used herein include therecited numbers (e.g., about 10%=10%), and also represent an amountclose to the stated amount that still performs a desired function orachieves a desired result. For example, the terms “approximately”,“about”, and “substantially” may refer to an amount that is within lessthan 10% of, within less than 5% of, within less than 1% of, within lessthan 0.1% of, and within less than 0.01% of the stated amount.

1. A polyp removal device, comprising: an outer tubular body having acylindrical outer surface, proximal and distal ends, and an opening inthe cylindrical outer surface near the distal end; an inner tubular bodypositioned within a lumen of the outer tubular body, the inner tubularbody having proximal and distal ends and being movable with respect tothe outer tubular body; a tubular cutter coupled to or formed as part ofthe distal end of the inner tubular body, the tubular cutter positionedadjacent the opening of the outer tubular body; a spring positioned tobias the inner tubular body in an extended direction with respect to theouter tubular body; a handle coupled to the proximal end of the outertubular body; an actuation member movably coupled to the handle, theactuation member configured to be manipulated by a user by at least oneof sliding or rotating the actuation member with respect to the handle,the actuation member configured to be movable in at least a firstdirection and a second direction with respect to the handle; and adisconnect mechanism for selectively coupling the actuation member tothe inner tubular body and decoupling the actuation member from theinner tubular body, the disconnect mechanism is configured to keep theinner tubular body coupled to the actuation member while the actuationmember is moved in the first direction for a predetermined distance,causing the inner tubular body to retract with respect to the outertubular body, the disconnect mechanism is further configured toautomatically decouple the inner tubular body from the actuation memberwhen the actuation member is moved in the first direction for a distancegreater than the predetermined distance, enabling the spring to causethe inner tubular body to extend with respect to the outer tubular body,and the disconnect mechanism is further configured to re-couple theinner tubular body to the actuation member when the actuation member ismoved in the second direction.
 2. The polyp removal device of claim 1,wherein the disconnect mechanism comprises: a rotatable connecting linkbiased in a direction that couples the inner tubular body to theactuation member; and a cam surface positioned to engage the connectinglink and cause the connecting link to rotate in a direction thatdecouples the inner tubular body from the actuation member, responsiveto movement of the actuating member in the first direction.
 3. The polypremoval device of claim 1, wherein the disconnect mechanism comprises:an elastically bendable connecting link biased in a direction thatcouples the inner tubular body to the actuation member; and a camsurface positioned to engage the connecting link and cause theconnecting link to bend in a direction that decouples the inner tubularbody from the actuation member, responsive to movement of the actuatingmember in the first direction.
 4. The polyp removal device of claim 1,wherein the first direction comprises translation of the actuationmember in a proximal direction with respect to the handle, and thesecond direction comprises translation of the actuation member in adistal direction with respect to the handle.
 5. The polyp removal deviceof claim 1, wherein the first direction comprises rotation of theactuation member in a clockwise or counterclockwise direction withrespect to the handle, and the second direction comprises rotation ofthe actuation member in a direction opposite to the first direction withrespect to the handle.
 6. The polyp removal device of claim 1, furthercomprising a cam mechanism configured to cause the inner tubular body torotate about a longitudinal axis as the inner tubular body extends withrespect to the outer tubular body.
 7. The polyp removal device of claim6, wherein the cam mechanism comprises a pin positioned at leastpartially within a helical groove, wherein the pin is coupled to orformed as part of one of the inner tubular body or the handle, and thehelical groove is coupled to or formed as part of the other of the innertubular body or the handle.
 8. The polyp removal device of claim 6,wherein the cam mechanism is configured to cause the inner tubular bodyto rotate no more than 180 degrees about the longitudinal axis as theinner tubular body extends with respect to the outer tubular body. 9.The polyp removal device of claim 6, wherein the cam mechanism isconfigured to cause the inner tubular body to rotate no more than 270degrees about the longitudinal axis as the inner tubular body extendswith respect to the outer tubular body.
 10. The polyp removal device ofclaim 1, further comprising: a cutting block positioned at the distalend of the outer tubular body and at least partially distal to theopening, the cutting block comprising a blunt rounded distal portionthat at least partially forms a distal tip of the polyp removal device,the cutting block further comprising a proximally extending cuttingportion positioned within the lumen of the outer tubular body, thecutting portion comprising a cylindrical outer surface, a concaveproximal face, and a cutting edge where the cylindrical outer surfacemeets the concave proximal face, wherein the tubular cutter is sized tofit at least partially within an annular shaped void between the lumenof the outer tubular body and the cylindrical outer surface of thecutting portion of the cutting block when the inner tubular body is inan extended position with respect to the outer tubular body.
 11. Thepolyp removal device of claim 10, wherein the tubular cutter comprises acircular cutting edge positioned at an inner diameter of a distal end ofthe tubular cutter.
 12. The polyp removal device of claim 1, wherein theouter tubular body comprises a distal cutting surface at a distal end ofthe opening, the distal cutting surface comprising a shape that is notperpendicular to a longitudinal axis of the outer tubular body.
 13. Thepolyp removal device of claim 1, wherein the outer tubular bodycomprises a distal cutting surface at a distal end of the opening, thedistal cutting surface comprising a shape that, when viewedperpendicular to a longitudinal axis of the outer tubular body andnormal to a center of the opening, comprises one or more roundedportions or comprises one or more portions that are oriented at anon-perpendicular angle with respect to the longitudinal axis.
 14. Thepolyp removal device of claim 1, wherein the outer tubular body isrotatably coupled to the handle, to allow the outer tubular body torotate about a longitudinal axis with respect to the handle.
 15. Thepolyp removal device of claim 11, wherein the outer tubular body isrotatably coupled to the handle via a hub, the hub comprising at leastone radially protruding member for engagement by a user to causerotation of the hub and outer tubular body with respect to the handle.16. The polyp removal device of claim 15, further comprising a balldetent mechanism configured to resist rotation of the hub with respectto the handle until a preload force of the ball detent mechanism isovercome, the ball detent mechanism comprising at least a ball, a ballpreload device, and a plurality of detents for the ball to engage. 17.The polyp removal device of claim 1, further comprising a second springpositioned to bias the actuation member in the second direction.
 18. Thepolyp removal device of claim 1, wherein the opening comprises proximaland distal ends, and the predetermined distance is sufficient to cause adistal end of the tubular cutter to retract at least to the proximal endof the opening before the disconnect mechanism automatically decouplesthe inner tubular body from the actuation member.
 19. The polyp removaldevice of claim 1, wherein the opening comprises proximal and distalends and a longitudinal length measured from the proximal to the distalend, wherein the predetermined distance is sufficient to cause a distalend of the tubular cutter to retract at least to within a longitudinaldistance from the proximal end of the opening before the disconnectmechanism automatically decouples the inner tubular body from theactuation member, and wherein the longitudinal distance is no greaterthan ⅓ of the longitudinal length of the opening. 20.-28. (canceled) 29.A polyp removal device, comprising: an outer tubular body having acylindrical outer surface, proximal and distal ends, and an opening inthe cylindrical outer surface near the distal end; an inner tubular bodypositioned within a lumen of the outer tubular body, the inner tubularbody having proximal and distal ends and being longitudinally androtationally movable with respect to the outer tubular body, the innertubular body comprising an extended position and a retracted positionwith respect to the outer tubular body; a tubular cutter coupled to orformed as part of the distal end of the inner tubular body, the tubularcutter positioned adjacent the opening of the outer tubular body; aspring positioned to bias the inner tubular body toward the extendedposition with respect to the outer tubular body; a handle coupled to theproximal end of the outer tubular body; a cam mechanism coupled to thehandle and configured to cause the inner tubular body to rotate about alongitudinal axis as the inner tubular body moves from the retractedposition to the extended position with respect to the outer tubularbody; and a disconnect mechanism coupled to the handle and configured toselectively retain the inner tubular body in the retracted position orrelease the inner tubular body from the retracted position, allowing thespring to move the inner tubular body toward the extended position.30.-43. (canceled)